Premarket Approval (PMA)

Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.

• Device: IMX(R) HAVAB
• Generic Name: Hepatitis a test (antibody and igm antibody)
• Regulation Number: 866.3310
• Applicant: Abbott Laboratories; 100 Abbott Park Rd.; D-049c/Ap6c-2; Abbott Park, IL 60064
• PMA Number: P780012
• Supplement Number: S007
• Date Received: 08/26/1992
• Decision Date: 09/12/1994
• Reclassified Date: 02/09/2006
• Product Code: LOL
• Advisory Committee: Microbiology
• Supplement Type: Normal 180 Day Track
• Supplement Reason: Location Change - Manufacturer/Sterilizer/Packager/Supplier
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No
• Recalls: CDRH Recalls