Premarket Approval (PMA)

Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.

• Trade Name: AUTOBAC MTS PLUS TEST SYTEM
• Classification Name: system, test, automated, antimicrobial susceptibility, short incubation
• Generic Name: microbial test system
• Regulation Number: 866.1645
• Applicant: WARNER-LAMBERT CO.
• PMA Number: P810024
• Supplement Number: S003
• Date Received: 10/18/1985
• Decision Date: 03/17/1986
• Product Code: LON [ Registered Establishments with LON ]
• Advisory Committee: Microbiology
• Expedited Review Granted?: No
• Combination Product: No