FDA 510(k)

FilmArray Gastrointestinal Panel (GI) for use with FilmArray Torch

Número K: K160459 · 2016-04-01

Data da decisão2016-04-01

Código do produtoPCH

Comité consultivoMI

DecisãoSubstantially Equivalent

Resumo do dispositivo

FilmArray Gastrointestinal Panel (GI) 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 2016-04-01 under 510(k) number K160459. The device is classified under product code PCH. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the FilmArray Gastrointestinal Panel (GI) for use with FilmArray Torch?

FilmArray Gastrointestinal Panel (GI) for use with FilmArray Torch is a medical device that received FDA 510(k) clearance on 2016-04-01. The listed applicant is Biofire Diagnostics, LLC. The 510(k) number is K160459.

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

FilmArray Gastrointestinal Panel (GI) for use with FilmArray Torch received FDA 510(k) clearance on 2016-04-01, under 510(k) number K160459.

Who is the listed applicant for FilmArray Gastrointestinal Panel (GI) 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 Gastrointestinal Panel (GI) for use with FilmArray Torch?

The FDA product code for FilmArray Gastrointestinal Panel (GI) for use with FilmArray Torch is PCH.

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