FDA 510(k)

FilmArray 呼吸检测板 (RP) 用于 FilmArray Torch

K号: K160068 · 2016-02-08

决定日期2016-02-08

产品代码OCC

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决定实质等同

器械摘要

FilmArray Respiratory Panel (RP) for use with FilmArray Torch 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 2016-02-08 under 510(k) number K160068. The device is classified under product code OCC. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the FilmArray Respiratory Panel (RP) for use with FilmArray Torch?

FilmArray Respiratory Panel (RP) for use with FilmArray Torch is a medical device that received FDA 510(k) clearance on 2016-02-08. The listed applicant is Biofire Diagnostics, LLC. The 510(k) number is K160068.

When did FilmArray Respiratory Panel (RP) for use with FilmArray Torch receive FDA 510(k) clearance?

FilmArray Respiratory Panel (RP) for use with FilmArray Torch received FDA 510(k) clearance on 2016-02-08, under 510(k) number K160068.

Who is the listed applicant for FilmArray Respiratory Panel (RP) for use with FilmArray Torch?

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 Respiratory Panel (RP) for use with FilmArray Torch?

The FDA product code for FilmArray Respiratory Panel (RP) for use with FilmArray Torch is OCC.

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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