|
Device | VITEK 2 SYSTEM, MODELS VITEK 2 AND VITEK 2 XL |
Generic Name | Susceptibility test cards, antimicrobial |
Applicant | BIOMERIEUX VITEK, INC. 595 ANGLUM DR. HAZELWOOD, MO 63042-2395 |
PMA Number | N50510 |
Supplement Number | S146 |
Date Received | 09/17/2001 |
Decision Date | 10/17/2001 |
Reclassified Date
|
12/28/2001 |
Product Codes |
LON 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 A LABELING CHANGE TO ADD AN INSTRUCTION TO THE VITEK 2 USER'S MANUAL WHICH DESCRIBES ADDITIONAL VISUAL OBSERVATION STEPS TO THE PROCEDURE FOR THE INSTALLATION OF THE VITEK 2 ACCESSORY KIT AND SALINE BAG. |