Premarket Approval (PMA)

Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements 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
• Date Received: 05/19/1981
• Decision Date: 03/04/1982
• Reclassified Date: 05/06/2003
• Product Code: LON [ Registered Establishments with LON ]
• Docket Number: 82M-0070
• Notice Date: 03/26/1982
• Advisory Committee: Microbiology
• Expedited Review Granted?: No
• Combination Product: No
• Supplements: S001 S002 S003 S004