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FDA 510(k)

ADVIA Centaur Cytokeratin Fragment 21-1

K-Number: K250925 · 2025-12-16

ApplicantFujirebio Diagnostics,Inc.
Decision Date2025-12-16
Product CodeOVK
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

ADVIA Centaur Cytokeratin Fragment 21-1 is the device name listed in this FDA 510(k) record. The listed applicant is Fujirebio Diagnostics,Inc.. It received FDA 510(k) clearance on 2025-12-16 under 510(k) number K250925. The device is classified under product code OVK. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ADVIA Centaur Cytokeratin Fragment 21-1?

ADVIA Centaur Cytokeratin Fragment 21-1 is a medical device that received FDA 510(k) clearance on 2025-12-16. The listed applicant is Fujirebio Diagnostics,Inc.. The 510(k) number is K250925.

When did ADVIA Centaur Cytokeratin Fragment 21-1 receive FDA 510(k) clearance?

ADVIA Centaur Cytokeratin Fragment 21-1 received FDA 510(k) clearance on 2025-12-16, under 510(k) number K250925.

Who is the listed applicant for ADVIA Centaur Cytokeratin Fragment 21-1?

The FDA 510(k) record lists Fujirebio Diagnostics,Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ADVIA Centaur Cytokeratin Fragment 21-1?

The FDA product code for ADVIA Centaur Cytokeratin Fragment 21-1 is OVK.

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Related Devices (Code: OVK)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K160915Elecsys CYFRA 21-1, Elecsys CYFRA 21-1 CalSet, PreciControl Tumor MarkerRoche Diagnostics

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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