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: MIC TEST PANELS
• Generic Name: SYSTEM, TEST, AUTOMATED, ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION
• Regulation Number: 866.1645
• Applicant: Microtech Medical Systems, Inc.; 13930 River Rd.; Potomic, MD 20854
• PMA Number: N50487
• Supplement Number: S015
• Date Received: 07/13/1983
• Decision Date: 03/01/1984
• Reclassified Date: 05/06/2003
• Product Code: LON
• Advisory Committee: Microbiology
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No