BACT/ALERT SN CULTURE BOTTLE


Device Classification Name

system, blood culturing

510(k) Number K021123
Device Name BACT/ALERT SN CULTURE BOTTLE
Original Applicant
BIOMERIEUX, INC.
100 rodolphe st
durham, 
NC 
27712

Original Contact ron sanyal
Regulation Number 866.2560
Classification Product Code
MDB  
Date Received 04/08/2002
Decision Date 04/26/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Microbiology

510k Review Panel

Microbiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls