FDA 510(k)

FilmArray RP EZ Control Panel M265

Número K: K161573 · 2016-09-02

RequerenteMaine Molecular Quality Controls, Inc.

Data da decisão2016-09-02

Código do produtoPMN

Comité consultivoMI

DecisãoSubstantially Equivalent

Resumo do dispositivo

FilmArray RP EZ Control Panel M265 is the device name listed in this FDA 510(k) record. The listed applicant is Maine Molecular Quality Controls, Inc.. It received FDA 510(k) clearance on 2016-09-02 under 510(k) number K161573. The device is classified under product code PMN. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the FilmArray RP EZ Control Panel M265?

FilmArray RP EZ Control Panel M265 is a medical device that received FDA 510(k) clearance on 2016-09-02. The listed applicant is Maine Molecular Quality Controls, Inc.. The 510(k) number is K161573.

When did FilmArray RP EZ Control Panel M265 receive FDA 510(k) clearance?

FilmArray RP EZ Control Panel M265 received FDA 510(k) clearance on 2016-09-02, under 510(k) number K161573.

Who is the listed applicant for FilmArray RP EZ Control Panel M265?

The FDA 510(k) record lists Maine Molecular Quality Controls, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FilmArray RP EZ Control Panel M265?

The FDA product code for FilmArray RP EZ Control Panel M265 is PMN.

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Outros registros que listam Maine Molecular Quality Controls, Inc. como candidato(a)

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Fonte oficial

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