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 a medical device manufactured by Fujirebio Diagnostics,Inc.. It received FDA 510(k) clearance on 2025-12-16 under approval 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. It is manufactured by Fujirebio Diagnostics,Inc.. The 510(k) number is K250925.
When was ADVIA Centaur Cytokeratin Fragment 21-1 approved by the FDA?
ADVIA Centaur Cytokeratin Fragment 21-1 received FDA 510(k) clearance on 2025-12-16, under approval number K250925.
What company makes ADVIA Centaur Cytokeratin Fragment 21-1?
ADVIA Centaur Cytokeratin Fragment 21-1 is manufactured by Fujirebio Diagnostics,Inc..
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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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.