K253653
- 510(k) number
- K253653
- Device name
- Xpert Hemorrhagic Fever
- Applicant
- Cepheid CA · US
- Decision date
- 2026-02-20
- Date received
- 2025-11-20
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Unknown
PDFDownload 510(k) SummaryArchived here · 2.8 MB · U.S. public domain
Also available from FDA: K253653.pdf
Official FDA record: K253653
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.