FDA 510(k)

ST AIA-PACK BNP

K号: K192380 · 2020-08-24

决定日期2020-08-24

产品代码NBC

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决定实质等同

器械摘要

ST AIA-PACK BNP 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 2020-08-24 under 510(k) number K192380. The device is classified under product code NBC. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the ST AIA-PACK BNP?

ST AIA-PACK BNP is a medical device that received FDA 510(k) clearance on 2020-08-24. The listed applicant is Fujirebio Diagnostics,Inc.. The 510(k) number is K192380.

When did ST AIA-PACK BNP receive FDA 510(k) clearance?

ST AIA-PACK BNP received FDA 510(k) clearance on 2020-08-24, under 510(k) number K192380.

Who is the listed applicant for ST AIA-PACK BNP?

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 ST AIA-PACK BNP?

The FDA product code for ST AIA-PACK BNP is NBC.

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 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

查看所有 17 个设备 →

官方来源

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器械摘要

常见问题

列明Fujirebio Diagnostics,Inc.为申报人的其他记录

相关器械（代码：NBC）

官方来源