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: Calypte HIV-1 Urine EIA
• Classification Name: test, hiv detection
• Generic Name: hiv detection test
• Regulation Number: 866.3956
• Applicant: Maxim Biomedical Inc; 1440 fourth street; Berkeley , CA 94710
• PMA Number: BP000009
• Supplement Number: S015
• Date Received: 04/28/2003
• Decision Date: 05/28/2003

• Decision: Approved
• Product Code: MZF [ Registered Establishments with MZF ]
• Advisory Committee: Microbiology
• Supplement Type: 30-Day Notice
• Expedited Review Granted?: No
• Third Party Review Elligble?: No
• Combination Product: No