VITEK 2 GRAM NEGATIVE TRIMETHOPRIM/SULFAMETHOAZOLE


Device Classification Name

system, test, automated, antimicrobial susceptibility, short incubation

510(k) Number K110106
Device Name VITEK 2 GRAM NEGATIVE TRIMETHOPRIM/SULFAMETHOAZOLE
Applicant
BIOMERIEUX, INC.
595 anglum rd.
hazelwood, 
MO 
63042

Applicant Contact jolyn tenllado
Correspondent
BIOMERIEUX, INC.
595 anglum rd.
hazelwood, 
MO 
63042

Correspodent Contact jolyn tenllado
Regulation Number 866.1645
Classification Product Code
LON  
Date Received 01/13/2011
Decision Date 11/30/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Microbiology

510k Review Panel

Microbiology

summary

summary

FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No

Combination Product

No