|
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 | S069 |
Date Received | 06/06/1995 |
Decision Date | 08/07/1996 |
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 REMOVAL OF LIMITATION FOR SUSCEPTIBILITY TESTING OF ENTEROCOCCI/VANCOMYCIN TESTING ON THE VITEK GENERAL SUSCEPTIBILITY CARD |