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FDA 510(k) Application Details - K142501
Device Classification Name
More FDA Info for this Device
510(K) Number
K142501
Device Name
Xpert Norovirus, GeneXpert Dx Systems (GX-I, GX-11, GX-IV, GX-XVI), GeneXpert Infinity-48 System, GeneXpert Infinity-48s System, GeneXpert Infinity-80 System
Applicant
CEPHEID
904 CARIBBEAN DRIVE
SUNNYVALE, CA 94089-1189 US
Other 510(k) Applications for this Company
Contact
KERRY J. FLOM
Other 510(k) Applications for this Contact
Regulation Number
More FDA Info for this Regulation Number
Classification Product Code
PCH
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
09/05/2014
Decision Date
11/26/2014
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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