Premarket Approval (PMA)

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 Name: system, test, home, hiv-1
• Generic Name: hiv testing service
• Applicant: Home Access Health Corporation; 2401 west hassell road suite 1510; Hoffman Estates , IL 60169 -5200
• PMA Number: BP950002
• Supplement Number: S005
• Date Received: 07/13/1998
• Decision Date: 08/14/1998

• Decision: Approved
• Product Code: MVZ
• Advisory Committee: Hematology
• Supplement Type: Special Supplement
• Expedited Review Granted?: No
• Third Party Review Elligble?: No
• Combination Product: No