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

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..

Clearance details

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

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