VITEK 2 GRAM NEGATIVE TRIMETHOPRIM/SULFAMETHOXAZOLE


Device Classification Name

system, test, automated, antimicrobial susceptibility, short incubation

510(k) Number K073406
Device Name VITEK 2 GRAM NEGATIVE TRIMETHOPRIM/SULFAMETHOXAZOLE
Applicant
BIOMERIEUX, INC.
595 anglum rd.
hazelwood, 
MO 
63042

Applicant Contact nancy weaver
Correspondent
BIOMERIEUX, INC.
595 anglum rd.
hazelwood, 
MO 
63042

Correspodent Contact nancy weaver
Regulation Number 866.1645
Classification Product Code
LON  
Date Received 12/04/2007
Decision Date 01/23/2008
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