VITEK 2 STREPTOCOCCUS ERYTHROMYCIN


Device Classification Name

system, test, automated, antimicrobial susceptibility, short incubation

510(k) Number K111976
Device Name VITEK 2 STREPTOCOCCUS ERYTHROMYCIN
Applicant
BIOMERIEUX, INC.
595 anglum rd.
hazelwood, 
MO 
63042

Applicant Contact jennifer chia-hsuan lin
Correspondent
BIOMERIEUX, INC.
595 anglum rd.
hazelwood, 
MO 
63042

Correspodent Contact jennifer chia-hsuan lin
Regulation Number 866.1645
Classification Product Code
LON  
Date Received 07/12/2011
Decision Date 02/17/2012
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