FDA 510(k)

FilmArray 肺炎检测板 plus

K号: K181324 · 2018-11-15

决定日期2018-11-15

产品代码QDS

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决定实质等同

器械摘要

FilmArray Pneumonia Panel plus 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 2018-11-15 under 510(k) number K181324. The device is classified under product code QDS. It was reviewed by the PA advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the FilmArray Pneumonia Panel plus?

FilmArray Pneumonia Panel plus is a medical device that received FDA 510(k) clearance on 2018-11-15. The listed applicant is Biofire Diagnostics, LLC. The 510(k) number is K181324.

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

FilmArray Pneumonia Panel plus received FDA 510(k) clearance on 2018-11-15, under 510(k) number K181324.

Who is the listed applicant for FilmArray Pneumonia Panel plus?

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 plus?

The FDA product code for FilmArray Pneumonia Panel plus is QDS.

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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