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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 K100818
Device Name ILLUMIGENE C. DIFFICILE, ILLUMIPRO-10 AND ILLUMIGENE C. DIFFICILE EXTERNAL CONTROL KIT, MODELS 280050, 610172, 279920
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 Received03/23/2010
Decision Date 07/09/2010
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
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