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: AMS GRAM-NEGITIVE ANTIMICROBIAL SUSCEPT. PANELS
• Generic Name: Susceptibility test cards, antimicrobial
• Regulation Number: 866.1640
• Applicant: Biomerieux Vitek, Inc.; 595 Anglum Dr.; Hazelwood, MO 63042
• PMA Number: N50510
• Supplement Number: S027
• Date Received: 04/14/1987
• Decision Date: 07/16/1987
• Reclassified Date: 12/28/2001
• Product Code: LTW
• Advisory Committee: Microbiology
• Supplement Type: Normal 180 Day Track
• Supplement Reason: Labeling Change - Indications/instructions/shelf life/tradename
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No