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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name reagents, clostridium difficile toxin
510(k) Number K081920
Device Name BD GENEOHM CDIFF ASSAY
Original Applicant
BD DIAGNOSTICS (GENEOHM SCIENCES, INC.)
6146 nancy ridge dr.
san diego,  CA  92121
Original Contact raymond boule
Regulation Number866.2660
Classification Product Code
LLH  
Date Received07/03/2008
Decision Date 12/19/2008
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
Recalls CDRH Recalls
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