MRSASELECT – EXTENDED INCUBATION


Device Classification Name

culture media, antimicrobial susceptibility test, excluding mueller hinton agar

510(k) Number K081212
Device Name MRSASELECT – EXTENDED INCUBATION
Applicant
BIO-RAD
163 cabot st.
beverly, 
MA 
01915

Applicant Contact fran white
Correspondent
BIO-RAD
163 cabot st.
beverly, 
MA 
01915

Correspodent Contact fran white
Regulation Number 866.1700
Classification Product Code
JSO  
Date Received 04/29/2008
Decision Date 06/13/2008
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