VRESELECT CULTURE MEDIUM


Device Classification Name

culture media, antimicrobial susceptibility test, excluding mueller hinton agar

510(k) Number K103684
Device Name VRESELECT CULTURE MEDIUM
Applicant
BIO-RAD
180 cabot street
beverly, 
MA 
01915

Applicant Contact fran white
Correspondent
BIO-RAD
180 cabot street
beverly, 
MA 
01915

Correspodent Contact fran white
Regulation Number 866.1700
Classification Product Code
JSO  
Date Received 12/17/2010
Decision Date 10/21/2011
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