|
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 | S078 |
Date Received | 10/06/1997 |
Decision Date | 12/08/1997 |
Reclassified Date
|
12/28/2001 |
Product Code |
LTW |
Advisory Committee |
Microbiology |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approvalf or the removal of the disclaimer for Ticarcillin/Clavulanic Acid when testing Pseudomonas aeruginosa. |