510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K253653Substantially Equivalent

Xpert Hemorrhagic Fever

Cepheid, Sunnyvale CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K253653 is the FDA 510(k) clearance record for Xpert Hemorrhagic Fever, cleared for Cepheid on . FDA records list 62 510(k) clearances for Cepheid, from to . As of , FDA records show no recalls naming K253653.

Clearance record

Decision date
Received
(92 days to decision)
Review panel
Unknown
Applicant
Cepheid 904 Caribbean Dr., Sunnyvale CA
510(k) summary
Summary PDF
Third party review
No