FDA 510(k)

FilmArray Respiratory Panel EZ (RP EZ)

Número K: K152579 · 2016-10-03

Data da decisão2016-10-03

Código do produtoOCC

Comité consultivoMI

DecisãoSubstantially Equivalent

Resumo do dispositivo

FilmArray Respiratory Panel EZ (RP EZ) 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 2016-10-03 under 510(k) number K152579. The device is classified under product code OCC. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the FilmArray Respiratory Panel EZ (RP EZ)?

FilmArray Respiratory Panel EZ (RP EZ) is a medical device that received FDA 510(k) clearance on 2016-10-03. The listed applicant is Biofire Diagnostics, LLC. The 510(k) number is K152579.

When did FilmArray Respiratory Panel EZ (RP EZ) receive FDA 510(k) clearance?

FilmArray Respiratory Panel EZ (RP EZ) received FDA 510(k) clearance on 2016-10-03, under 510(k) number K152579.

Who is the listed applicant for FilmArray Respiratory Panel EZ (RP EZ)?

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 EZ (RP EZ)?

The FDA product code for FilmArray Respiratory Panel EZ (RP EZ) is OCC.

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