Cepheid - FDA 510(k) Cleared Devices
60
Total
57
Cleared
3
Denied
56 devices
Cleared
Sep 29, 2008
XPERT MRSA/SA BLOOD CULTURE ASSAY
Microbiology
61d
Cleared
Sep 24, 2008
XPERT MRSA/SA SSTI ASSAY
Microbiology
183d
Cleared
Apr 17, 2007
XPERT MRSA
Microbiology
60d
Not Cleared
Mar 16, 2007
XPERT EV, MODEL GXEV-100N-10
Microbiology
4d
Cleared
Dec 08, 2006
SMART GBS AND SMARTCYCLE DX SYSTEM AND SOFTWARE, VERSION 1.7B
Microbiology
71d
Cleared
Jul 25, 2006
XPERT, GENEXPERT DX SYSTEM
Microbiology
146d