Medical Device Manufacturer · US , Sunnyvale , CA

Cepheid - FDA 510(k) Cleared Devices

60 submissions · 57 cleared · Since 2006
Official Website
60
Total
57
Cleared
3
Denied

FDA 510(k) cleared devices by Cepheid Pathology ✕

2 devices
1-2 of 2
Cleared Sep 27, 2019
Xpert BCR-ABL Ultra, GeneXpert Dx System, GeneXpert Infinity-48s and...
K190076 · OYX
Pathology · 254d
Cleared Sep 18, 2009
XPERT HEMOSIL FACTOR II & FACTOR V ASSAY
K082118 · NPQ
Pathology · 417d
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