VITEK 2 GRAM NEGATIVE PIPERACILLIN/TAZOBACTAM


Device Classification Name

system, test, automated, antimicrobial susceptibility, short incubation

510(k) Number K080107
Device Name VITEK 2 GRAM NEGATIVE PIPERACILLIN/TAZOBACTAM
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 01/15/2008
Decision Date 02/28/2008
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

Recalls CDRH Recalls