Documento fuente o registro público
FDA 510(k) K250925 — ADVIA Centaur Cytokeratin Fragment 21-1
FDA 510(k) index record K250925. Device: ADVIA Centaur Cytokeratin Fragment 21-1. Applicant as listed: Fujirebio Diagnostics,Inc.. Decision date: 2025-12-16.
Fuente
"device_name": "ADVIA Centaur Cytokeratin Fragment 21-1"
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Automated FDA record verification
2026-10-20
2026-10-23
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FDA 510(k) public index record K250925.
Device name: ADVIA Centaur Cytokeratin Fragment 21-1. Applicant as listed: Fujirebio Diagnostics,Inc..
Decision date: 2025-12-16. Decision wording: Substantially Equivalent.
Product code: OVK. Regulation: 21 CFR 866.6010. Medical specialty: Immunology.
This page reproduces regulator index metadata. The applicant field identifies the submitter and is not a manufacturer identity check. Consult the original FDA record for the decision and associated documents; this index does not verify current commercial availability or clinical performance.
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