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 SYSTEMS GENERAL SUSCEPTIBILITY CARD |
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 | S083 |
Date Received | 07/09/1998 |
Decision Date | 09/15/1998 |
Reclassified Date
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12/28/2001 |
Product Code |
LTW |
Docket Number | N |
Advisory Committee |
Microbiology |
Supplement Type | Normal 180 Day Track |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for the removal of a limitation for the testing of Pseudomonas aeruginosa with the antibiotic cefepime. |
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