VITEK 2 GRAM POSITIVE INDUCIBLE CLINDAMYCIN RESISTANCE


Device Classification Name

system, test, automated, antimicrobial susceptibility, short incubation

510(k) Number K080201
Device Name VITEK 2 GRAM POSITIVE INDUCIBLE CLINDAMYCIN RESISTANCE
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 01/28/2008
Decision Date 04/30/2008
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