|
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 | S070 |
Date Received | 03/29/1996 |
Decision Date | 04/22/1996 |
Reclassified Date
|
12/28/2001 |
Product Code |
LTW |
Advisory Committee |
Microbiology |
Supplement Type | Special (Immediate Track) |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR THE ADDITION OF A LIMITATION STATEMENT REQUIRING A ALTERNATE METHOD OF TESTING FOR PIPERACLLIN IN SUSCEPTIBILITY TESTING OF PSEUDOMONAS AERUGINOSA |