VITEK 2 STREPTOCOCCUS INDUCIBLE CLINDAMYCIN RESISTANCE


Device Classification Name

system, test, automated, antimicrobial susceptibility, short incubation

510(k) Number K111909
Device Name VITEK 2 STREPTOCOCCUS INDUCIBLE CLINDAMYCIN RESISTANCE
Applicant
BIOMERIEUX, INC.
595 anglum rd.
hazelwood, 
MO 
63042

Applicant Contact nathan hardesty
Correspondent
BIOMERIEUX, INC.
595 anglum rd.
hazelwood, 
MO 
63042

Correspodent Contact nathan hardesty
Regulation Number 866.1645
Classification Product Code
LON  
Date Received 07/05/2011
Decision Date 10/18/2011
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