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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements 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
Date Received06/01/1995
Decision Date07/22/1996
Decision Approved
Product Code
MVZ
Advisory Committee Hematology
Expedited Review Granted? No
Third Party Review Elligble? No
Combination ProductNo
Supplements: S001 S002 S003 S004 S005 S007 S008 S009 S013 
S017 S027 S029 
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