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FDA 510(k) Application Details - K172126
Device Classification Name
More FDA Info for this Device
510(K) Number
K172126
Device Name
Xpert Xpress Strep A
Applicant
Cepheid
904 Caribbean Drive
Sunnyvale, CA 94089 US
Other 510(k) Applications for this Company
Contact
Yi-Ping Lin
Other 510(k) Applications for this Contact
Regulation Number
More FDA Info for this Regulation Number
Classification Product Code
PGX
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
07/14/2017
Decision Date
09/25/2017
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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