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: E COLI EXTENSION
• Generic Name: Susceptibility test cards, antimicrobial
• Regulation Number: 866.1640
• Applicant: BIOMERIEUX VITEK, INC.; 595 ANGLUM DR.; HAZELWOOD, MO 63042-2395
• PMA Number: N50510
• Supplement Number: S001
• Date Received: 04/24/1979
• Decision Date: 08/01/1979
• Reclassified Date: 12/28/2001
• Product Code: LTW
• Advisory Committee: Microbiology
• Expedited Review Granted?: No
• Combination Product: No