K250925

Substantially Equivalent

ADVIA Centaur Cytokeratin Fragment 21-1

Applicant: Fujirebio Diagnostics,Inc.
Product 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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