Software is listed in alphabetical order by applicant.
| Applicant |
Device Name |
510(k) Number |
Clearance Date |
Abbott Laboratories
100 Abbott Park Road
Abbott Park, IL 60064 |
Abbott Apheresis Tracking System (AARTS) Version 1.0 |
BK950048 |
6/24/1998 |
Abbott Laboratories
100 Abbott Park Road
Abbott Park, IL 60064 |
Abbott DMS II Version 1.5 |
BK950052 |
8/12/1998 |
Abbott Laboratories
100 Abbott Park Road
Abbott Park, IL 60064 |
Abbott DMS Version 3.0.2 |
BK950032 |
8/18/1998 |
Abbott Laboratories
100 Abbott Park Road
Abbott Park, IL 60064-3500 |
Abbott Prism Retest |
BK010036 |
7/17/2002 |
ADAC HealthCare Information System
5 Greenway Plaza, Suite 1900
Houston, TX 77046 |
LabCare Blood Bank II Version 13.3 |
BK960027 |
8/12/1998 |
American Blood Resources Association
PO Box 669
Annapolis, MD 21404 |
National Donor Deferral Registry Version 2.0 |
BK960030 |
3/20/1997 |
American Blood Resources Association
147 Old Solomons Island Road
Annapolis, MD 21401 |
National Donor Deferral Registry Ver 1.0 |
BK010012 |
9/6/2001 |
American Red Cross
Washington, DC 20006 |
National Biomedical Computer System, Version 1.1 |
BK960040 |
2/28/1997 |
American Red Cross Blood Services
Arlington, VA 22209 |
NGTL Automation system (NAS) 5.2.0 |
BK020032 |
3/20/2003 |
Bayer Corp
800 Dwight Way
Berkeley, CA 94701 |
Plasma Procurement Information System Version 2.0 |
BK960051 |
8/7/1998 |
Bayer Corp
800 Dwight Way
Berkeley, CA 94701 |
Plasma Procurement Information System (PPIS), version 3.0 |
BK990024 |
11/3/1999 |
Bayer Corp
800 Dwight Way
Berkeley, CA 94701 |
Plasma Procurement Information System (PPIS), version 4.0 |
BK990037 |
11/17/1999 |
Baxter Healthcare Corp
550 North Brand Blvd
Glendale, CA 91203 |
Serology SQL LIMS 1.0 |
BK020002 |
8/7/2002 |
Blood Bank Computer Systems, Inc
1002 15th SW, Suite 120
Auburn, WA 98001-6502 |
Blood Bank Control System (BBCS) 5.0 |
BK040056 |
10/22/2004 |
Blood Bank Computer Systems, Inc
1501 West Valley Hwy, Suite 101
Auburn, WA 98001 |
Blood Bank Control System Version 4.0/4.1/4.2/4.3 |
BK960044 |
10/15/1997 |
Carter BloodCare
2205 Highway 121
Bedford, TX 76021 |
LifeTrak / Distribution, version 2.03 |
BK990015 |
10/22/1999 |
Carter BloodCare
2205 Highway 121
Bedford, TX 76021 |
LifeTrak / Donor, version 2.03 |
BK990027 |
12/15/1999 |
Cerner Corp
2800 Rockcreek Parkway
Kansas City, MO 64117 |
PathNet Blood Bank Center Version 306 |
BK950051 |
7/16/1997 |
Cerner Corp
2800 Rockcreek Parkway
Kansas City, MO 64117 |
PathNet Blood Bank Transfusion Version 306 |
BK950053 |
7/16/1997 |
Cerner Corp
2800 Rockcreek Parkway
Kansas City, MO 64117 |
PathNet Blood Bank Donor Version 306 |
BK950055 |
7/16/1997 |
Cerner Corp
2800 Rockcreek Parkway
Kansas City, MO 64117 |
PathNet Worksystems Blood Bank Transfusion Version 306 |
BK960024 |
7/16/1997 |
Cerner Corp
2800 Rock Creek Parkway
Kansas City, MO 64117 |
HNA Millennium PathNet Blood Bank Transfusion |
BK990007 |
11/2/1999 |
Cerner Corp
2800 Rock Creek Parkway
Kansas City, MO 64117 |
Cerner Millennium PathNet Blood Bank Donor (PA-22200) 2003.01 |
BK030028 |
8/19/2003 |
Community Bio-Resources, Inc
2197 Parkway Lake Drive
Hoover, AL 35244 |
Donor Information System Version 1.0 |
BK970007 |
4/9/1997 |
Community Blood Center of Greater Kansas City
4040 Main Street
Kansas City, MO 64117 |
CBC Blood System Version 1.2 |
BK960060 |
11/20/1997 |
Data Innovations, Inc.
120 Kimball Ave., Suite 100
South Burlington, VT 05430 |
imExpress 7.2.5 |
BK020057 |
7/29/2003 |
Department of Defense
5 Skyline Plaza
Falls Church, VA 22047 |
Defense Blood Standard System Versions 1.00/1.03 |
BK960004 |
8/1/1997 |
Department of Defense
5113 Leesburg Pike, Suite 701
Falls Church, VA 22041 |
Defense Blood Standard System Version 3.00 |
BK980031 |
8/31/1998 |
Department Of Veterans Affairs
P.O. Box 5000
VA Hines Medical Center
Hines, IL 60141 |
Vista Blood Bank, Version 5.2 |
BK970021 |
4/23/1999 |
Digi-Trax
1550 Barclay Blvd
Buffalo Grove, IL 60089 |
Donor - ID Version 1.0 |
BK970013 |
2/27/1998 |
Digi-Trax
1550 Barclay Blvd
Buffalo Grove, IL 60089 |
Digi-Trax Donor-ID Version 2.0 |
BK000020 |
4/20/2000 |
Digi-Trax
1550 Barclay Blvd
Buffalo Grove, IL 60089 |
Donor-ID 2.2 |
BK010049 |
4/26/2002 |
Dynamic Healthcare Techonologies, Inc
101 Southhall Lane, Suite 210
Maitland, FL 32751 |
Transfusion Service Manager Version 4.1.6 |
BK960041 |
12/16/1997 |
Fifth Dimension Information Systems
Suite 500, 10025- 102A Avenue
Edmonton, Alberta T5J 2Z2
CANADA
|
LOGIC 2.0 |
BK040040 |
10/6/2004 |
Fifth Dimension Information Systems
Suite 500
Midland Walwyn Tower
Edmonton Centre
Edmonton, Alberta
Canada T5J2Z2 |
Plasma Center Module, Version 1.0 |
BK980025 |
5/18/1999 |
Fifth Dimension Information Systems
Suite 500 Merril Lynch Tower
Edmonton Centre
Edmonton, Canada |
Donor Management System, version 1.0.0 |
BK990022 |
9/10/1999 |
Fifth Dimension Information Systems
Suite 500
Edmonton, Alberta
Cananda T5J2Z2 |
P2K Plasma Center Module 2000 Version 1.0 |
BK000026 |
6/22/2000 |
Fifth Dimension Information Systems
Suite 500, Merril Lynch Tower
Edmonton Centre
Edmonton, Alberta, T5J 2Z2
CANADA |
LOGIC 1.0 |
BK020058 |
2/3/2003 |
Gambro BCT, Inc
10811 W. Collins Ave
Lakewood, CO 80215-4498 |
Vista Information System, Independent Solution |
BK020015 |
7/15/2002 |
Gambro BCT, Inc
10811 W. Collins Ave
Lakewood, CO 80215-4498 |
Vista Information System 2.1 |
BK030021 |
5/1/2003 |
Gen-Probe
10210 Genetic Center Drive
San Diego,CA 92121-4362 |
The Chiron Procleix System |
BK000051 |
2/8/2002 |
Gen-Probe
10210 Genetic Center Drive
San Diego,CA 92121-4362 |
Chiron Procleix System |
BK000045 |
11/21/2002 |
Healthcare-ID
1635 Barclay Blvd.
Buffalo Grove, IL 60089 |
Donor-ID version 2.5 |
BK030049 |
10/31/2003 |
Helmer Labs, Inc
15425 Herriman Boulevard
Noblesville, IN 46060 |
UltraCW (with Software version 3.13) |
BK020029 |
10/4/2002 |
Information Data Management, Inc
9701 West Higgins Rd
Rosemont, IL 60018 |
Components and Distribution Information System Version 1.0 |
BK950037 |
8/26/1996 |
Information Data Management, Inc
9701 West Higgins Rd
Rosemont, IL 60018 |
Donor Mgmt. Information System Version 1.2 |
BK950045 |
8/26/1996 |
Information Data Management, Inc
9701 West Higgins Road
Rosemont, IL 60018 |
Plasma Center Management System Version 1.0 |
BK980020 |
7/31/1998 |
Information Data Management, Inc
9701 West Higgins Road
Rosemont, IL 60018 |
Plasma Center Management System Version 1.1 |
BK980028 |
9/4/1998 |
Information Data Management, Inc
9701 West Higgins Road
Rosemont, IL 60018 |
Surround System 1.0 |
BK990016 |
8/27/1999 |
Information Data Management, Inc
9701 West Higgins Road
Rosemont, IL 60018 |
Plasma Center Management System (PCMS), Version 1.2 |
BK990029 |
10/13/1999 |
Information Data Management, Inc
9701 West Higgins Road
Rosemont, IL 60018 |
Plasma Center Management System (PCMS), Version 2.0 |
BK990046 |
1/6/2000 |
Information Data Management, Inc
9701 West Higgins Road
Rosemont, IL 60018 |
Surround System 2.0 |
BK000016 |
4/7/2000 |
Information Data Management Systems, Inc
9701 west Higgins Road
Rosemont, IL 60018 |
Surround System, Version 3.2 |
BK020038 |
10/8/2002 |
Informedics, Inc
4000 Kruse Way Place, Building 3
Lake Oswego, OR 97035 |
Lifeline Blood Bank Management System Release 4.2 |
BK950064 |
7/1/1998 |
LifeTrak/BloodCare
9000 Harry Hines Blvd.
Dallas, TX 75235 |
Lab Version 2.01 |
BK940048 |
10/1/1998 |
MAK System
Z.1. Paris Nord II
13, Rue de la Perdix
B.P. 50035
95946 Roissy C.D.G. CEDEX, France |
Progesa, Version 4.4a |
BK960050 |
12/10/1998 |
Medical Information Technology
Meditech Circle
Westwood, MA 02090 |
Meditech Magic Blood Bank, Version 4.5/4.6 |
BK960029 |
3/19/1999 |
Medical Information Technology
Meditech Circle
Westwood, MA 02090 |
Magic Client Server, Version 5.1 |
BK980046 |
2/8/2000 |
Mediware Information Systems, Inc
4545 Fuller Drive, Ste 320
Irving, TX 75038 |
HCLL 2.6 |
BK030078 |
4/8/2004 |
Mediware Information Systems, Inc
9000 Harry Hines Blvd
Dallas, TX 75235 |
LifeTrak Lab 2.03 |
BK010052 |
6/17/2002 |
Mediware Information Systems, Inc
1121 Old Walt Whitman Road
Melville, NY 11747 |
Hemocare Blood Bank Management System Version 5.2 |
BK980034 |
12/10/1998 |
Mediware Information Systems, Inc
900 Oakmont Lane
Westmont, IL, 60659 |
Hemocare LifeLine Version, 1.0 |
BK020046 |
2/14/2003 |
Medserv, Inc
71 South Bedford Road
Mount Kisco, NY 10549 |
Plasmapheresis Data System III 1.0 |
BK010032 |
2/5/2002 |
Micro Typing Systems Inc
1295 S.W. 29th Ave.
Pompano Beach, FL 33069 |
Ortho ProVue, Software Version: 2.10 |
BK030023 |
5/30/2003 |
Misys Healthcare Systems
4801 East Broadway Boulevard
Tucson, AZ 85711
|
Misys Laboratory Blood Bank and Blood Donor 6.0.1 |
BK040065 |
10/22/2004 |
Ortho-Clinical Diagnostics, Inc
1001 U.S. Highway 202
Raritan, NJ 08869 |
Ortho Lab with Ortho Lab IC (Instrument Concentrator), Version 1.0 |
BK990030 |
4/3/2000 |
Psyche Systems Corp
Ten Laurel Avenue
Wellesley, MA 02481 |
System Blood Bank (SBB) Ver. 3.0 |
BK010017 |
9/4/2001 |
Rubin & Poor, Inc
155 Maplewood Avenue #5
Maplewood, NJ 07040 |
Configurable Manual Batch Entry, Verion 1.1A |
BK030073 |
1/14/2004 |
Rubin & Poor, Inc
155 Maplewood Avenue #5
Maplewood, NJ 07040 |
Configurable Laboratory Result Manager (CLRM) 1.0E |
BK000030 |
11/23/2001 |
Rubin & Poor, Inc
150 West 25th Street, Suite 600
New York, NY 10001 |
Rubin & Poor Configurable Manual Blot System, version 1.0C |
BK990008 |
10/29/1999 |
Rubin & Poor, Inc
155 Maplewood Avenue #5
Maplewood, NJ 07040 |
Chiron Procleix NAT Tracker 1.0E |
BK010025 |
1/3/2002 |
Sanguin International
1020 Sherman Avenue
Hamden, CT 06514 |
Medussa 2000 Srimport, version 1.2 |
BK980039 |
6/11/1999 |
Sanguin International Limited
1020 Sherman Avenue
Hamden, CT 06514 |
Aurora / Fenestra 1.0 |
BK980003 |
9/29/1999 |
Shared Medical Systems
51 Valley Stream Parkway
Malvern, PA 19355 |
SMS Blood Bank Transfusion System Versions 2.0/3.0/4.0 |
BK960036 |
12/12/1997 |
Soft Computer Consultant
34350 US Highway 19 North
Palm Harbor, FL 34684 |
Softbank II Version 19.1 |
BK960033 |
7/10/1998 |
Soft Computer Consultants
34350 US Highway 19 North
Palm Harbor, FL 34684 |
Softbank II Version 21.1 |
BK000040 |
4/20/2001 |
Soft Computer Consultants, Inc
34350 U.S. HWY 19 N
Palm Harbor, FL 34684 |
SoftBank II 22 |
BK020021 |
9/11/2002 |
Soft Computer Consultants, Inc
34350 U.S. Hwy 19 N
Palm Harbor, FL, 34684 |
SoftDonor 4.1 |
BK020006 |
2/27/2003 |
Soft Computer Consultants, Inc
34350 U.S. HWY 19 N
Palm Harbor, FL 34684 |
SoftBank II 23 |
BK030018 |
4/17/2003 |
Soft Computer Consultants, Inc
34350 U.S. HWY 19 N
Palm Harbor, FL 34684 |
SoftBank II version 23 with SoftScape |
BK040028 |
5/7/2004 |
Sunquest Information Systems
4801 Broadway Boulevard
Tucson, AZ 85711 |
Flexilab Blood Bank and Blood Donor, Version 5.2 |
BK990002 |
8/16/1999 |
Sunquest Information Systems, Inc
4801 Broadway Boulevard
Tucson, AZ 85711 |
FlexiLab Blood Bank and Blood Donor System, version 5.2 |
BK990034 |
11/17/1999 |
Systec Computer Associates, Inc
28 North Country Road
Mt. Sinai, NY 11766 |
LifeTec Donor Verification and Collection System (DOVAC) 1.00 |
BK040026 |
10/21/2004 |
Systec Computer Associates, Inc
28 North Country Road
Mt. Sinai, NY 11766 |
LifeTec, Version 2.20 |
BK990003 |
7/30/1999 |
SysTec Computer Associates
28 North Country Road
Mt. Sinai, NY 11766 |
LifeTec Community Blood Center System Revision 2.10 |
BK960034 |
7/28/1998 |
Talisman Ltd
421 Church Street NE. Suite F
Vienna, VA 22180 |
Quality Donor System 2004 2.0 |
BK040062 |
10/18/2004 |
Wyndgate Technologies
11121 Sun Center Drive, Suite C
Rancho Cordova, CA 95670 |
Safe Trace Version 1.0 |
BK950059 |
4/14/1997 |
Wyndgate Technologies
111212 Sun Center Drive, Suite C
Rancho Cordova, CA 95670 |
SafeTrace TX, Version 1.0 |
BK980023 |
1/29/1999 |
ZLB Bioplasma AG
Wannkdorfstrasse 10
Bern, Switzerland |
System for Plasma Identififcation (SPI) 1.0 |
BK020020 |
10/30/2002 |
