PREMIER C. DIFFICILE GDH


Device Classification Name

antigen, c. difficile

510(k) Number K110620
Device Name PREMIER C. DIFFICILE GDH
Applicant
MERIDIAN BIOSCIENCE, INC.
3471 river hills dr.
cincinnati, 
OH 
45244

Applicant Contact susan bogar
Correspondent
MERIDIAN BIOSCIENCE, INC.
3471 river hills dr.
cincinnati, 
OH 
45244

Correspodent Contact susan bogar
Regulation Number 866.2660
Classification Product Code
MCB  
Date Received 03/03/2011
Decision Date 05/03/2011
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