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: 3M BRAND MICROBIAL PROFILE SYSTEM
• Generic Name: SYSTEM, TEST, AUTOMATED, ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION
• Regulation Number: 866.1645
• Applicant: Flow Laboratories, Inc.; 7655 Old Springhouse Rd.; Mclean, VA 22102
• PMA Number: N50538
• Supplement Number: S001
• Date Received: 03/02/1981
• Decision Date: 04/17/1981
• Reclassified Date: 05/06/2003
• Product Code: LON
• Advisory Committee: Microbiology
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No