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: HEPANOSTIKA(TM) ANTI-HAV MIDROELISA SYSTEM
• Generic Name: Hepatitis a test (antibody and igm antibody)
• Regulation Number: 866.3310
• Applicant: Organon Teknika Corp.; 100 Akzo Ave.; Durham, NC 27712
• PMA Number: P830018
• Supplement Number: S001
• Date Received: 08/25/1989
• Decision Date: 03/21/1990
• 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