ADVIA Centaur Cytokeratin Fragment 21-1— 510(k) K250925

Name: FDA 510(k) clearance K250925
Creator: U.S. Food and Drug Administration
Published: 2025-12-16

Substantially Equivalent

Fujirebio Diagnostics,Inc.

FDA 510(k) clearance K250925 for ADVIA Centaur Cytokeratin Fragment 21-1, Substantially Equivalent on 2025-12-16. Applicant: Fujirebio Diagnostics,Inc.. Device class: 2.

Clearance details

Applicant: Fujirebio Diagnostics,Inc.
Product code: Code OVK
Device class: Class 2
Regulation: 21 CFR 866.6010
Advisory panel: Immunology
Date received: 2025-03-27
Decision date: 2025-12-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Malvern, PA, US

Download summary PDF View on FDA.gov ↗

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