FDA 510(k)

ADVIA Centaur 鳞状细胞癌相关抗原21-1

K号: K250925 · 2025-12-16

决定日期2025-12-16

产品代码OVK

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决定实质等同

器械摘要

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.

常见问题

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.

列明Fujirebio Diagnostics,Inc.为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K242706Lumipulse G pTau217/β-淀粉样蛋白 1-42 血浆比值 K192524Lumipulse G CA15-3 K192380ST AIA-PACK BNP K200997Lumipulse G CA19-9-N K190702Lumipulse G 全部 PTH K172713Lumipulse G B•R•A•H•M•S PCT 免疫反应卡，Lumipulse G B•R•A•H•M•S PCT 校准器套件

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