|
Device | VITEK 2 ADVANCED EXPERT SYSTEM SOFTWARE |
Generic Name | Susceptibility test cards, antimicrobial |
Applicant | BIOMERIEUX VITEK, INC. 595 ANGLUM DR. HAZELWOOD, MO 63042-2395 |
PMA Number | N50510 |
Supplement Number | S103 |
Date Received | 08/11/1999 |
Decision Date | 11/10/1999 |
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 Vitek(R) 2 Advanced Expert System as an optional software accessory for the Vitek(R) 2 Susceptibility Test System. |