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FDA 510(k) Application Details - K143302
Device Classification Name
More FDA Info for this Device
510(K) Number
K143302
Device Name
Xpert MTB/RIF Assay, GeneXpert Dx, GeneXpert Infinity-48, GeneXpert Infinity-48s, GeneXpert Infinity-80
Applicant
CEPHEID
904 CARIBBEAN DRIVE
SUNNYVALE, CA 94089-1189 US
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Contact
KERRY J FLOM
Other 510(k) Applications for this Contact
Regulation Number
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Classification Product Code
PEU
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
11/17/2014
Decision Date
02/12/2015
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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