VITEK 2 AST STREPTOCOCUS VANCOMYCIN


Device Classification Name

system, test, automated, antimicrobial susceptibility, short incubation

510(k) Number K121100
Device Name VITEK 2 AST STREPTOCOCUS VANCOMYCIN
Applicant
BIOMERIEUX, INC.
595 anglum rd.
hazelwood, 
MO 
63042

Applicant Contact jocelyn jennings
Correspondent
BIOMERIEUX, INC.
595 anglum rd.
hazelwood, 
MO 
63042

Correspodent Contact jocelyn jennings
Regulation Number 866.1645
Classification Product Code
LON  
Date Received 04/11/2012
Decision Date 11/19/2012
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

Category: Uncategorized