|
Device | VITEK GRAM NEGATIVE SUSCEPTIBILITY CARD-AMPICILLIN/SULBACTAM |
Generic Name | Susceptibility test cards, antimicrobial |
Applicant | BIOMERIEUX VITEK, INC. 595 ANGLUM DR. HAZELWOOD, MO 63042-2395 |
PMA Number | N50510 |
Supplement Number | S087 |
Date Received | 05/24/1999 |
Decision Date | 07/09/1999 |
Reclassified Date
|
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 removal of a limitation for the testing of Enterobacter cloacae with the antibiotic ampicillin/sulbactam. |