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FDA 510(k) Application Details - K110203
Device Classification Name
More FDA Info for this Device
510(K) Number
K110203
Device Name
XPERT C. DIFFICLE/EPI ASSAY
Applicant
CEPHEID
904 CARIBBEAN DRIVE
SUNNYVALE, CA 94089-1189 US
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Contact
RUSSEL K ENNS
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Regulation Number
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Classification Product Code
OMN
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Date Received
01/24/2011
Decision Date
04/07/2011
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
MI - Microbiology
Review Advisory Committee
MI - Microbiology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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