|
Device | VITEK PIPERACILLIN/TAZOBACTAM |
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 | S064 |
Date Received | 08/08/1994 |
Decision Date | 11/27/1995 |
Reclassified Date
|
12/28/2001 |
Product Code |
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 ANTIMICROBIAL PIPERACILLIN/TAZOBACTAM TO THE VITEK GRAM NEGATIVE ANTIMICROBIAL PANELS |