|
Device | MICROSCAN RAPID FLUOROGENIC PANELS |
Generic Name | SYSTEM, TEST, AUTOMATED, ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION |
Regulation Number | 866.1645 |
Applicant | DADE INTL., INC. 1584 ENTERPRISE BLVD. WEST SACRAMENTO,, CA 95691 |
PMA Number | P870049 |
Supplement Number | S029 |
Date Received | 06/10/1999 |
Decision Date | 06/24/1999 |
Reclassified Date
|
05/06/2003 |
Product Code |
LON |
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 to not report results for the testing of Escherichia coli and Klebsiella spp. with the antibiotic ticarcillin/K clavulanate in either the Minimal Inhibitory Concentration (MIC) or the Breakpoint Panels. |