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FDA 510(k) Application Details - K161619
Device Classification Name
More FDA Info for this Device
510(K) Number
K161619
Device Name
Xpert TV, Xpert Urine Specimen Collection Kit, GeneXpert Dx Systems (GX-I, GX-II, GX-IV, GX-XVI), GeneXpert Infinity-48, Genxpert Infinity-48s and GeneXpert Infinity-80 Systems
Applicant
Cepheid
904 Carribean Drive
Sunnyvale, CA 94089-1189 US
Other 510(k) Applications for this Company
Contact
Scott A. Campbell
Other 510(k) Applications for this Contact
Regulation Number
More FDA Info for this Regulation Number
Classification Product Code
OUY
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
06/13/2016
Decision Date
08/29/2016
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
IM - Immunology
Review Advisory Committee
MI - Microbiology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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