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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
Model 280050, 610172
Device Name ILLUMIGENE C. DIFFICILE, AND ILLUMIPRO-10
Original Applicant
MERIDIAN BIOSCIENCE, INC.
3471 river hills dr.
cincinnati,  OH  45244
Original Contact michelle l smith
Regulation Number866.2660
Classification Product Code
OMN  
Date Received01/03/2011
Decision Date 02/24/2011
Decision substantially equivalent - CLIA submission (CS)
Classification Advisory Committee Microbiology
Review Advisory Committee Microbiology
summary summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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