K250218
- 510(k) number
- K250218
- Device name
- Xpert® FII & FV
- Applicant
- Cepheid CA · US
- Product code
- NPR — Test, Factor Ii G20210a Mutations, Genomic Dna Pcr
- Decision date
- 2025-02-21
- Date received
- 2025-01-24
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Hematology
PDFDownload 510(k) SummaryArchived here · 2.5 MB · U.S. public domain
Also available from FDA: K250218.pdf
Official FDA record: K250218
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.