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 NEGATIVE AST FOR AMOXICILLIN/CLAVULANIC ACID |
Generic Name | Susceptibility test cards, antimicrobial |
Applicant | BIOMERIEUX VITEK, INC. 595 ANGLUM DR. HAZELWOOD, MO 63042-2395 |
PMA Number | N50510 |
Supplement Number | S124 |
Date Received | 10/14/1999 |
Decision Date | 03/20/2000 |
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 Approval for the addition of the antibiotic amoxicillin/clavulanic acid at concentrations of 4/2, 16/8, and 32/16ug/ml to the Vitek 2 Gram Negative Susceptibility Test System. |
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