FDA 510(k)

FilmArray 肺炎面板

K号: K212727 · 2021-09-22

决定日期2021-09-22

产品代码QDP

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决定实质等同

器械摘要

FilmArray Pneumonia Panel is the device name listed in this FDA 510(k) record. The listed applicant is Biofire Diagnostics, LLC. It received FDA 510(k) clearance on 2021-09-22 under 510(k) number K212727. The device is classified under product code QDP. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the FilmArray Pneumonia Panel?

FilmArray Pneumonia Panel is a medical device that received FDA 510(k) clearance on 2021-09-22. The listed applicant is Biofire Diagnostics, LLC. The 510(k) number is K212727.

When did FilmArray Pneumonia Panel receive FDA 510(k) clearance?

FilmArray Pneumonia Panel received FDA 510(k) clearance on 2021-09-22, under 510(k) number K212727.

Who is the listed applicant for FilmArray Pneumonia Panel?

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

What is the FDA product code for FilmArray Pneumonia Panel?

The FDA product code for FilmArray Pneumonia Panel is QDP.

列明Biofire Diagnostics, LLC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。

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