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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 K110203
Device Name XPERT C. DIFFICLE/EPI ASSAY
Applicant
CEPHEID
904 CARIBBEAN DRIVE
SUNNYVALE,  CA  94089 -1189
Applicant Contact RUSSEL K ENNS
Correspondent
CEPHEID
904 CARIBBEAN DRIVE
SUNNYVALE,  CA  94089 -1189
Correspondent Contact RUSSEL K ENNS
Regulation Number866.2660
Classification Product Code
OMN  
Date Received01/24/2011
Decision Date 04/07/2011
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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