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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 toxin gene amplification assay
510(k) Number K130470
Device Name BD MAX CDIFF ASSAY, BD MAX INSTRUMENT
Original Applicant
GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS)
2555 boul. du parc-technologique
quebec,  CA g1p 4s5
Original Contact patricia dionne
Regulation Number866.3130
Classification Product Code
OZN  
Subsequent Product Code
OOI  
Date Received02/27/2013
Decision Date 04/02/2013
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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