Substantially Equivalent 510(k) Device Information This list reflects information regarding the applications as of the approval date. It is not updated with regard to applicant or application status changes. Information is arranged in alphabetical order by the name of the applicant Applicant 510K Number Product Date Activated Cell Therapy, Inc Mountain View, CA BK960002 ACT Buoyant Density Solution 8/12/1996 Alpha Scientific Corp Southeastern, PA BK940054 SEG-SAFE 3/15/1995 Alpha Therapeutic Corp City of Industry, CA BK950044 Transfer Device 10/18/1995 American Blood Resources Association Annapolis, MD BK010012 National Donor Deferral Registry (NDDR) 1.0 8/30/2001 American Blood Resources Association Annapolis, MD BK960030 National Donor Deferral Registry 3/20/1997 American Red Cross Blood Services Arlington, VA BK20032 NGTL Automation System (NAS) 5.2.0 3/20/2003 Applied Biosystems / Celera Diagnostics Alameda, CA 94502 BK030005 ViroSeq HIV-1 Genotyping System with the 3100 Genetic Analyzer 1/29/2003 Applied Science, Inc Grass Valley, CA 95945 BK010031 Hemoflow Model 400 with Data Scanner 1/23/2002 Arlington Scientific, Inc Springville, UT 84663 BK020031 ASI TPHA Test 1/30/2003 Baxter Healthcare Corp - Transfusion Therapies Division Round Lake, IL BK040059 Amicus Separator System 9/24/2004 Baxter Healthcare Corp Round Lake, IL BK020059 ALYX Component Collection System 1/23/2003 Baxter Healthcare Corp Round Lake, IL BK020056 ALYX System 12/20/2002 Baxter Healthcare Corp Round Lake, IL BK020008 LeukoConnect 12/16/2002 Baxter Healthcare Corp Round Lake, IL BK010033 Cygnet System 8/27/2002 Baxter Healthcare Corp Round Lake, IL BK000039 Amicus Separator, Concurrent Collection of Red Blood Cells 8/26/2002 Baxter Healthcare Corp Round Lake, IL BK000047 Amicus Separator, Mononuclear Cell Collection 7/31/2002 Baxter Healthcare Corp Round Lake, IL BK990009 Fenwal Amicus Separator Collection of Three Platelet Products 3/3/2000 Baxter Healthcare Corp Round Lake, IL BK980041 Sepacell Pre-Storage Leukocyte Set for Red Cells 7/16/1999 Baxter Healthcare Corp Round Lake, IL BK940009 Optipress Automated Blood Component Extractor 5/18/1994 Baxter Healthcare Corp Round Lake, IL BK920003 Fenwal Needle/Tube Sampling Protector and Needle Safety Cover 3/12/1992 BD Biosciences San Jose, CA 95131-1807 BK030027 BD IMAGN Microvolume Fluorimeter and BD IMAGN rWBC Assay Kit 7/10/2003 Beckman Coulter, Inc Miami, FL 33196-2500 BK040032 Stem-Kit Reagents 5/5/2004 Beckman Coulter, Inc Miami, FL 33196-2500 BK020063 LeukoSure Enumeration Kit with Leuko-Trol RBC Control Cells and Leuko Trol Platelet Control Cells 2/3/2003 Beckman Coulter, Inc Miami, FL 33196-2500 BK010044 stemONE System for EPICS XL/XL-MCL Flow Cytometry Systems 5/20/2002 Becton, Dickinson & Company Franklin Lakes, NJ 07417-1885 BK040030 BD Vacutainer Plus Plastic Serum Tubes with Clot Activator 5/5/2004 BioErgonomics, Inc St. Paul, MN BK000046 FluoroTrol Control Kits 4/2/2001 BioMerieux, Inc Durham, NC 27712 BK030076 BacT/ALERT BPA Culture Bottles 3/8/2004 BioMerieux, Inc Durham, NC 27712 BK030075 BacT/ALERT BPN Culture Bottles 3/8/2004 BioMerieux, Inc Durham, NC 27712 BK030034 BacT/ALERT BPN Culture Bottle 7/18/2003 BioMerieux, Inc Durham, NC 27712 BK020022 BacT/ALERT SN Culture Bottle 10/10/2002 BioMerieux, Inc Durham, NC 27712 BK020023 BacT/ALERT SA Culture Bottle 10/10/2002 BioMerieux, Inc Durham, NC 27712 BK000042 BacT/ALERT Culture Bottles 2/15/2002 Biomet,Inc. Warsaw, IN BK040036 GPS II Platelet Concentrate Separation Kit 6/24/2004 Biometric Imaging, Inc Mountain View, CA BK970015 CEQer RBC Assay 9/18/1998 Biometric Imaging, Inc Mountain View, CA BK970016 CEQer PRP Assay 9/18/1998 Biometric Imaging, Inc Mountain View, CA BK970018 STELLer CD34 Assay 8/18/1998 Biotest Diagnostics Corp Denville, NJ BK960061 Biotest DQB-ELPHA 8/4/1997 Biotest Diagnostics Corp Denville, NJ BK960086 Biotest High Resolution Supplementary Kit 7/3/1997 Blood Bank Computer Systems, Inc Auburn, WA BK040056 Blood Bank Control System (BBCS) 5.0 10/22/2004 Boston Biomedica, Inc West Bridgewater, MA BK040064 ACCURUN 345 HIV-1 RNA, HCV RNA, HBV DNA Positive Quality Control Series 150l 10/29/2004 Boston Biomedica, Inc West Bridgewater, MA BK040006 ACCURUN 315 HIV-1 RNA Positive Control 10/12/2004 Boston Biomedica, Inc West Bridgewater, MA BK990032 Accurun 106 HIV-1 Antigen 1/20/2000 Cascade Medical Enterprises, LLC Wayne, NJ BK020051 Cascade Medical Fibrinet, Autologous Platelet System 12/20/2002 Celera Diagnostics Alameda, CA BK030033 ViroSeq HIV-1 Genotyping System with the 3700 Genetic Analyzer 6/11/2003 Celera Diagnostics/Applied Biosystems, Inc Alameda, CA BK010024 ViroSeq HIV-1 Genotyping System 12/10/2002 Cerner Corporation Kansas City, MO BK030028 Cerner Millennium PathNet Blood Bank Donor (PA-22200) 2003.01 8/19/2003 COBE BCT Lakewood, CO BK990025 COBE Trima 4/7/2000 COBE BCT Lakewood, CO BK970005 Focussed System 10/13/1998 Community Bio-Resources, Inc Hoover, AL BK970007 Donor Information System, Version 1.0 4/9/1997 Data Innovations, Inc.. South Burlington, VT BK020057 imExpress 7.2.5 7/29/2003 DENCO, Inc Wilmington, DE BK000022 Total Containment Device 4/18/2000 DENCO, Inc Wilmington, DE BK990041 Total Containment Device TCD 12/21/1999 Digi-Trax Corp Buffalo Grove, IL BK010049 Donor-ID 2.2 4/26/2002 Digi-Trax Corp Buffalo Grove, IL BK000020 Digi-Trax Donor-ID 2.0 4/20/2000 Digi-Trax Corp Buffalo Grove, IL BK970013 DONOR-ID, version 1.0 2/27/1998 Dynal Biotech Ltd Bromborough, Wirral, UK BK030056 Dynal Reli SSO HLA-A Typing Kit 1/29/2004 Dynal Biotech Ltd Bromborough, Wirral, UK BK030057 Dynal Reli SSO HLA-B Typing Kit 1/29/2004 Dynal Biotech Ltd Bromborough, Wirral, UK BK030058 Dynal Reli SSO HLA-Cw Typing Kit 1/29/2004 Dynal Biotech Ltd Bromborough, Wirral, UK BK030059 Dynal Reli SSO HLA-DQB1 Typing Kit 1/29/2004 Dynal Biotech Ltd Bromborough, Wirral, UK BK030060 Dynal Reli SSO HLA-DRB Typing System 1/29/2004 Dynamic Healthcare Technologies, Inc Maitland, FL BK960041 Transfusion Service Manager, Version 4.1.6 12/16/1997 Fifth Dimension Information Systems Edmonton, Alberta T5J 2Z2 CANADA BK040040 LOGIC 2.0 10/6/2004 Fifth Dimension Information Systems Edmonton, Alberta T5J 2Z2 BK020058 LOGIC 1.0 2/3/2003 Fresenius Hemocare Inc Lexington, MA 02420 BK040005 Fresenius Compoguard & Donationmaster NT 3/26/2004 Fresenius Hemocare Inc Redmond, WA 98052 BK030022 Fresenius Compomat G4 & Compomaster NT 7/11/2003 Fujirebio Diagnostics, Inc Malvern, PA BK030007 Olympus PK TP System 2/21/2003 Gambro BCT, Inc Lakewood, CO 80215-4498 BK040069 Trima Automated Blood Component Collection System - Blood Component Sampling Accessary 10/28/2004 Gambro BCT, Inc Lakewood, CO 80215-4498 BK010037 Platelet collection sets for the COBE Spectra Apheresis System and the Trima Automated Blood Component Collection System 9/24/2003 Gambro BCT, Inc Lakewood, CO 80215-4498 BK030021 Vista Information System 2.1 5/1/2003 Gambro BCT, Inc Lakewood, CO 80215-4498 BK020041 COBE Spectra Apheresis System/Blood component disposable collection sets for apheresis 4/23/2003 Gambro BCT, Inc Lakewood, CO 80215-4498 BK010050 Trima Automated Blood Collection System 9/18/2002 Gambro BCT, Inc Lakewood, CO 80215-4498 BK010046 Trima Automated Blood Collection System (Single Stage) 9/18/2002 Gambro BCT, Inc Lakewood, CO 80215-4498 BK020015 Vista Information System, Independent Solution 7/15/2002 Gambro BCT, Inc Lakewood, CO 80215-4498 BK010006 Trima Automated Blood Component Collection System 2/27/2002 Genetic Testing Institute Brookfield, WI BK960059 PAKAUTO Platelet Antibody Screening Kit 10/22/1998 Greiner Bio-One GmbH Westmont, IL 60659 BK030032 Greiner Vacuette EDTA K2 Evacuated Blood Collection Tube 7/18/2003 Greiner Bio-One GmbH Westmont, IL 60659 BK030001 Greiner Vacuette EDTA K3 Tube 2/26/2003 GTI, INC Waukesha, WI 53186 BK040034 Lifecodes LifeScreen: A Luminex 100 Screening Assay for the Detection of IgG Antibodies to HLA Class I and Class II Molecules of Human Origin 7/16/2004 GTI, INC Waukesha, WI 53186 BK040035 Lifecodes ID Class I: A Luminex 100 screening assay for the qualitative detection of IgG panel reactive antibodies (PRA) to HLA Class I molecules Lifecodes ID Class II: A Luminex 100 screening assay for the qualitative detection of IgG panel reactive antibodies (PRA) to HLA Class II molecules 7/16/2004 GTI, INC Waukesha, WI 53186 BK040019 Antibody Monitoring System Class 1 and Class II (AMS1 and AMS1+2) 7/6/2004 Haemonetics Corp Braintree, MA 02184 BK040041 Haemonetics MCS+8150 Apheresis System 07/12/2004 Haemonetics Corp Braintree, MA 02184 BK040025 PCS2 Plasma Collection System 06/02/2004 Haemonetics Corp Braintree, MA 02184 BK040020 Haemonetics LN994CF-BA Extended Storage Platelet and Plasma Apheresis Set with Leukocyte Reduction Filter, and 4 mL Sampling System 03/29/2004 Haemonetics Corp Braintree, MA 02184 BK040001 Haemonetics 4mL Sampling System 02/27/2004 Haemonetics Corp Braintree, MA 02184 BK030062 Haemonetics Model 215 Automated Glycerolyzation/deglycerolyzation System 12/10/2003 Haemonetics Corp Braintree, MA 02184 BK030031 Haemonetics Model 215 Automated Glycerolyzation/deglycerolyzation and Cell Washing System 9/10/2003 Haemonetics Corp Braintree, MA 02184 BK010035 MCS+ Mobile Collection System 12/20/2002 Haemonetics Corp Braintree, MA 02184 BK020001 Plasma Pooling Bottle II 3/29/2002 Haemonetics Corp Braintree, MA 02184 BK000002 Model 215 Automated Glycerlization and Deglycerolization System 5/4/2001 Haemonetics Corp Braintree, MA 02184 BK000048 Haemonetics LN832F 4/9/2001 Haemonetics Corp Braintree, MA 02184 BK990033 MCS+ LN8150 Red Cell Apheresis Instrument 1/20/2000 Harvest Technologies Norwell, MA BK000037 Harvest PRP Separation System 2/5/2001 Helmer Labs, Inc Noblesville, IN 46060 BK020029 UltraCW (with Software version 3.13) 10/04/2002 Healthcare-ID Buffalo Grove, IL BK030049 Donor-ID 10/31/2003 Hemasure, Inc Marlborough, MA BK980014 HemaSure r|LS Pre-Storage Leukoreduction Filtration System for Red Blood Cells 5/27/1999 HemoCue, Inc Potomac, MD BK030067 HemoCue Donor Hb Checker System 12/19/2003 HemoCue, Inc Potomac, MD BK030020 Donor Hemoglobin Checker System 4/17/2003 HemoCue, Inc Potomac, MD BK000043 HemoCue Low Hemoglobin Analyzing System 4/9/2001 Hemosystem, S.A. Richmond, VA BK040031 Scansytem Bacterial Detection Device 9/23/2004 Immucor, Inc Norcross, GA BK040057 Check cell (Weak) 10/6/2004 Immucor, Inc Norcross, GA BK040024 Capture-R Select Solid Phase System 4/28/2004 Immucor, Inc Norcross, GA BK040013 Galileo version 1.3.6 SP4/DMS version 1.26 4/23/2004 Immucor, Inc Norcross, GA BK000024 ABS2000, Version 2 software (2.05.00A and 2.0500B) 7/3/2001 Immucor, Inc Norcross, GA BK960019 ABS2000 6/30/1998 Indico, Inc Edmonton, ALBERTA T6G 2E1 CANADA BK000008 RadTag X-ray 3/1/2000 Information Data Management, Inc Rosemont, IL 60018 BK020038 Surround System, Version 3.2 10/8/2002 Information Data Management, Inc Rosemont, IL 60018 BK010028 IDM Surround System 3.0 8/30/2001 Information Data Management, Inc Rosemont, IL 60018 BK000016 Information Data Management Surround System 2.0 4/7/2000 Information Data Management, Inc Rosemont, IL 60018 BK950037 Components & Distribution Information System 8/26/1996 Information Data Management, Inc Rosemont, IL 60018 BK950045 Donor Management Information Systems, vers.1.2 8/26/1996 Infra-Med Technologies, Inc Dallas, TX BK990018 Hot Shot Fluid Warmer 10/13/1999 ITL Corporation, Ltd Fyshwick, Canberra, Australia BK980008 Bloodpack Needle Protector (BNP) 4/7/1998 Kowa Company, Ltd Rockville, MD 20852 BK030037 LD-2000 Leukocyte Counter 6/14/2004 Level 1 Technologies, Inc Rockland, MA 02370 BK020043 Level 1 Fluid warming System 6/16/2003 Ljungber & Kogel Deerfield, IL BK990013 Biomixer 330 & Biomixer 323 7/7/1999 Maco Pharma c/o Hoppe Regulatory Consultants Decatur, GA BK030008 Leucolab LCG2 Leukoreduction System for Red Blood Cells 5/2/2003 MEDITECH Medical Information Technology, Inc Westwood, MA BK980046 Magic Client Server, Version 5.1 2/8/2000 Mediware Information Systems, Inc Irving, TX 75038 BK040047 Instrument Interface Engine 1.0 7/16/2004 Mediware Information Systems, Inc Irving, TX 75038 BK030078 HCLL 2.6 4/8/2004 Mediware Information Systems, Inc Dallas, TX 75235 BK010052 LifeTrak Lab 2.03 6/17/2002 Mediware Information Systems, Inc Dallas, TX 75235 BK020046 Hemocare LifeLine Version, 1.0 2/14/2003 Medsep Corp Covina, CA BK020014 Pall Bacterial Detection System (BDS) 10/22/2002 Medsep Corp Covina, CA BK000032 Modified Plasma Bag 9/27/2000 Medsep Corp Covina, CA BK970040 Medsep Plasma Bag (EVA Plastic) 1/23/1998 Medserv, Inc Mount Kisco, NY 10549 BK010032 Plasmapheresis Data System III 1.0 2/5/2002 Medtronic Sofamor Danek Memphis, TN 38132 BK030040 Magellan Autologous Platelet Separation System 9/3/2003 Micro Typing Systems Inc. Pompano Beach, FL BK030023 Ortho ProVue, Software Version: 2.10 05/30/2003 Microwave Medical System Acton, MA BK970045 ThermoStat 900 Blood & IV Fluid Adm. Set 03/6/1998 Microwave Medical System Acton, MA BK970044 ThermoStat 900 1/23/1998 Mississippi Blood Services, Inc. Jackson, MS BK030065 WebLab Online Laboratory System 2.0 12/22/2003 Misys Healthcare Systems Tucson, AZ 85711 BK040065 Misys Laboratory Blood Bank and Blood Donor 6.0.1 10/22/2004 One Lambda, Inc Canoga Park, CA BK040049 LabType Visual 8/9/2004 One Lambda, Inc Canoga Park, CA BK030069 LABScreen Products for use with LABScan 100 flow analyzer 12/31/2003 One Lambda, Inc Canoga Park, CA BK980015 FlowPRA 7/23/1999 One Lambda, Inc Canoga Park, CA BK960062 Micro SSP HLA Class II DNA typing Kit 2/11/1998 OriGen BioMedical Austin, TX 78758 BK030036 OriGen Cryostore Freezing Bags 10/1/2003 Ortho-Clinical Diagnostics, Inc Raritan, NJ 08869-0606 BK990030 Ortho Lab with Ortho Lab IC (Instrument Concentrator) 4/3/2000 Pel-Freez Clinical Systems, LLC Brown Deer, WI 53223 BK000019 UniTray SSP HLA Typing Kits 1/29/2001 Pel-Freez Clinical Systems, LLC Brown Deer, WI 53223 BK030003 UniMatch Plus 2/25/2003 Psyche Systems Corp Wellesley, MA 02481 BK010017 System Blood Bank (SBB) Software 3.0 9/4/2001 R & D Systems, Inc Minneapolis, MN BK040063 R & D Plasma Hemoglobin Hematology Control 9/17/2004 R & D Systems, Inc Minneapolis, MN BK040012 R&D; Donor Checker Hematology Control 3/5/2004 R & D Systems, Inc Minneapolis, MN BK000035 R & D Leuko-Reduced RBC Control 12/13/2000 R & D Systems, Inc Minneapolis, MN BK000036 R & D Leuko-Reduced Plt Control 12/13/2000 Rubin & Poor, Inc Maplewood, NJ 07040 BK030073 Configurable Manual Batch Entry, Version 1.1A 1/14/2004 Rubin & Poor, Inc Maplewood, NJ 07040 BK010025 Chiron Procleix NAT Tracker 1.0E 1/3/2002 Rubin & Poor, Inc Maplewood, NJ 07040 BK000030 Configurable Laboratory Result Manager (CLRM) 1.0E 11/23/2001 Rubin & Poor, Inc Maplewood, NJ 07040 BK990008 Rubin & Poor Configurable Manual Blot System 1.0C 10/29/1999 Sanguin International Limited Hambden, CT BK980003 Aurora / Fenestra 1.0 9/29/1999 Sarstedt, Inc Newton, NC 28658 BK030006 Transwaag Disk 01 2/27/2003 Sarstedt, Inc Newton, NC 28658 BK010045 Sahara Blood & Plasma Warming Device 12/21/2001 Sarstedt, Inc Newton, NC 28658 BK010042 Transwaag KL 12/12/2001 SCIMEDX Corp Denville, NJ BK960070 Olympus PK-TP System Control Set 6/19/1997 SG SCientific Gainesville, FL BK950057 The Saber, (Segment Piercing Device) 11/13/1995 Shared Medical Systems Malvern, PA BK960036 SMS Blood Bank Transfusion System 12/12/1997 Sienna Partners Baldwin, MD BK040066 Greiner VACUETTE No Additive Evacuated Blood Collection Tubes and Serum Clot Activator Blood Collection Tubes 9/10/2004 Sienna Partners Baldwin, MD BK040018 VACUETTE EDTA K2 tube; VACUETTE EDTA K3 tube 7/28/2004 Soft Computer Consultants, Inc Palm Harbor, FL BK040048 SoftBank II v23.1 with Database Management System Interface (DMSI) 8/23/2004 Soft Computer Consultants, Inc Palm Harbor, FL BK040028 SoftBank II version 23 with SoftScape 5/7/2004 Soft Computer Consultants, Inc Palm Harbor, FL BK030018 SoftBank II 23 4/17/2003 Soft Computer Consultants, Inc Palm Harbor, FL BK020006 SoftDonor 4.1 2/27/2003 Soft Computer Consultants, Inc Palm Harbor, FL BK020021 SoftBank II 22 9/11/2002 Stemco Biomedical, Incorporated Durham, NC BK030064 Aldecount Progenitor Cell Enumeration Kit 12/31/2003 SysTec Computer Associates, Inc Mt. Sinai, NY BK040026 LifeTec Donor Verification and Collection System (DOVAC) 1.00 10/21/2004 Talisman Ltd Vienna, VA BK040062 Quality Donor System 2004 2.0 10/18/2004 Terumo Medical Corp Elkton, MD BK020033 Imugard III-PL Leukocyte reduction filter 5/22/2003 Terumo Medical Corp Elkton, MD BK970011 Terumo Phlebotomy Needle Cap Holder 6/19/1997 Thermogenesis Rancho Cordova, CA BK960072 CryoSeal System 2/12/1999 Utah Medical Products, Inc Midvale, UT BK970026 Umbilicup 1/28/1998 VEEGEE Scientific Kirkland, WA 98034 BK010043 Atago SP-D2 Refractometer 1/2/2002 Visible Genetics, Inc Toronto, Ontario BK000038 TRUEGENE HIV-1 Genotyping Kit and OpenGene DNA Sequencing System 9/26/2001 Wyndgate Technologies Rancho Cordova, CA BK980023 SafeTrace TX, version 1.0 1/29/1999 ZLB Bioplasma AG Bern, Switzerland BK020020 System for Plasma Identification (SPI) 1.0 10/30/2002

Updated November 1, 2004

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