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. |
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Device | VITEK 2 GRAM POSITIVE AST FOR AMPICILLIN/SULBACTAM |
Generic Name | Susceptibility test cards, antimicrobial |
Applicant | BIOMERIEUX VITEK, INC. 595 ANGLUM DR. HAZELWOOD, MO 63042-2395 |
PMA Number | N50510 |
Supplement Number | S125 |
Date Received | 10/25/1999 |
Decision Date | 03/31/2000 |
Reclassified Date
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12/28/2001 |
Product Codes |
LON LTW |
Advisory Committee |
Microbiology |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement This device will be marketed as Vitek 2 which tests for the antibiotic ampicillin/sulbactam at concentrations of 4/2, 8/4, 16/8 and 64/32 micrograms per milliliter. |
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