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Premarket Approval Information - Devices

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Product: Home Access HIV-1 Test System
Applicant: Home Access Health Corp., Hoffman Estates, IL
PMA number: BP950002
Indication for use: For self-use by people who wish to obtain anonymous HIV testing.
Approval Date: 7/22/96

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Letter - (PDF), (Text)

Summary - (PDF)

Label - (PDF)

 

Updated March 1, 2001
 
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