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: MS 2 MICROBIAL SYSTEM
• Generic Name: SYSTEM, TEST, AUTOMATED, ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION
• Regulation Number: 866.1645
• Applicant: Abbott Laboratories; 100 Abbott Park Rd.; Dept 9va Ap6c-2; Abbott Park, IL 60064
• PMA Number: N50525
• Supplement Number: S001
• Date Received: 07/16/1979
• Decision Date: 01/10/1980
• Withdrawal Date: 12/10/2007
• Product Code: LON
• Advisory Committee: Microbiology
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No