FDA 510(k)

Lumipulse G CA19-9-N

K号: K200997 · 2020-05-14

决定日期2020-05-14

产品代码NIG

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决定实质等同

器械摘要

Lumipulse G CA19-9-N 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 2020-05-14 under 510(k) number K200997. The device is classified under product code NIG. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Lumipulse G CA19-9-N?

Lumipulse G CA19-9-N is a medical device that received FDA 510(k) clearance on 2020-05-14. The listed applicant is Fujirebio Diagnostics,Inc.. The 510(k) number is K200997.

When did Lumipulse G CA19-9-N receive FDA 510(k) clearance?

Lumipulse G CA19-9-N received FDA 510(k) clearance on 2020-05-14, under 510(k) number K200997.

Who is the listed applicant for Lumipulse G CA19-9-N?

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 Lumipulse G CA19-9-N?

The FDA product code for Lumipulse G CA19-9-N is NIG.

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。

K250925ADVIA Centaur 鳞状细胞癌相关抗原21-1 K242706Lumipulse G pTau217/β-淀粉样蛋白 1-42 血浆比值 K192524Lumipulse G CA15-3 K192380ST AIA-PACK BNP 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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