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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Device Home Access HIV-1 Test System
Classification Namesystem, test, home, hiv-1
Generic Namehiv testing service
Applicant
Home Access Health Corporation
2401 west hassell road suite 1510
Hoffman Estates , IL 60169 -5200
PMA NumberBP950002
Supplement NumberS008
Date Received02/26/2001
Decision Date06/05/2001
Decision Approved
Product Code
MVZ
Advisory Committee Hematology
Supplement TypeNormal 180 Day Track
Expedited Review Granted? No
Third Party Review Elligble? No
Combination ProductNo
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