K250925
- 510(k) number
- K250925
- Device name
- ADVIA Centaur Cytokeratin Fragment 21-1
- Applicant
- Fujirebio Diagnostics,Inc. PA · US
- Product code
- OVK — Cytokeratin Fragments 21-1 Eia Kit
- Decision date
- 2025-12-16
- Date received
- 2025-03-27
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Immunology
PDFDownload 510(k) SummaryArchived here · 3.6 MB · U.S. public domain
Also available from FDA: K250925.pdf
Official FDA record: K250925
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.