FDA 510(k)

FilmArray RP2/RP2plus Control Panel

Número K: K173171 · 2017-11-24

RequerenteMaine Molecular Quality Controls, Inc.

Data da decisão2017-11-24

Código do produtoPMN

Comité consultivoMI

DecisãoSubstantially Equivalent

Resumo do dispositivo

FilmArray RP2/RP2plus Control Panel 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 2017-11-24 under 510(k) number K173171. 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 RP2/RP2plus Control Panel?

FilmArray RP2/RP2plus Control Panel is a medical device that received FDA 510(k) clearance on 2017-11-24. The listed applicant is Maine Molecular Quality Controls, Inc.. The 510(k) number is K173171.

When did FilmArray RP2/RP2plus Control Panel receive FDA 510(k) clearance?

FilmArray RP2/RP2plus Control Panel received FDA 510(k) clearance on 2017-11-24, under 510(k) number K173171.

Who is the listed applicant for FilmArray RP2/RP2plus Control Panel?

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 RP2/RP2plus Control Panel?

The FDA product code for FilmArray RP2/RP2plus Control Panel is PMN.

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Fonte oficial

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