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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name test, factor v leiden mutations, genomic dna pcr
510(k) Number K082118
Device Name XPERT HEMOSIL FACTOR II & FACTOR V ASSAY
Original Applicant
CEPHEID
904 caribbean drive
sunnyvale,  CA  94089 1189
Original Contact russel k enns
Regulation Number864.7280
Classification Product Code
NPQ  
Subsequent Product Codes
NPR   OOI  
Date Received07/28/2008
Decision Date 09/18/2009
Decision substantially equivalent - CLIA submission (CS)
Classification Advisory Committee Hematology
Review Advisory Committee Hematology
summary summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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