ILLUMIGENE C. DIFFICILE, AND ILLUMIPRO-10


Device Classification Name

c. difficile nucleic acid amplification test assay

510(k) Number K110012
Device Name ILLUMIGENE C. DIFFICILE, AND ILLUMIPRO-10
Applicant
MERIDIAN BIOSCIENCE, INC.
3471 river hills dr.
cincinnati, 
OH 
45244

Applicant Contact michelle l smith
Correspondent
MERIDIAN BIOSCIENCE, INC.
3471 river hills dr.
cincinnati, 
OH 
45244

Correspodent Contact michelle l smith
Regulation Number 866.2660
Classification Product Code
OMN  
Date Received 01/03/2011
Decision Date 02/24/2011
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

Recalls CDRH Recalls