Premarket Approval (PMA)

Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.

• Device: AUTOBAC MTS PLUS TEST SYTEM
• Generic Name: SYSTEM, TEST, AUTOMATED, ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION
• Regulation Number: 866.1645
• Applicant: WARNER-LAMBERT CO.; 201 TABOR RD., MORRIS PLAINS N; J
• PMA Number: P810024
• Date Received: 05/19/1981
• Decision Date: 03/04/1982
• Reclassified Date: 05/06/2003
• Product Code: 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