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U.S. Department of Health and Human Services

510(k) Premarket Notification
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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
Correspondent Contact Michelle L Smith
Regulation Number866.2660
Classification Product Code
OMN  
Date Received01/03/2011
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
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