FDA 510(k)

FilmArray Pneumonia/Pneumoniaplus Control

N.º K: K190222 · 2019-05-03

SolicitanteMaine Molecular Quality Controls, Inc.

Fecha de decisión2019-05-03

Código de productoPMN

Comité asesorMI

DecisiónSubstantially Equivalent

Resumen del dispositivo

FilmArray Pneumonia/Pneumoniaplus Control 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 2019-05-03 under 510(k) number K190222. The device is classified under product code PMN. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the FilmArray Pneumonia/Pneumoniaplus Control?

FilmArray Pneumonia/Pneumoniaplus Control is a medical device that received FDA 510(k) clearance on 2019-05-03. The listed applicant is Maine Molecular Quality Controls, Inc.. The 510(k) number is K190222.

When did FilmArray Pneumonia/Pneumoniaplus Control receive FDA 510(k) clearance?

FilmArray Pneumonia/Pneumoniaplus Control received FDA 510(k) clearance on 2019-05-03, under 510(k) number K190222.

Who is the listed applicant for FilmArray Pneumonia/Pneumoniaplus Control?

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 Pneumonia/Pneumoniaplus Control?

The FDA product code for FilmArray Pneumonia/Pneumoniaplus Control is PMN.

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Otros registros que enlistan a Maine Molecular Quality Controls, Inc. como solicitante

K260577FilmArray TF Control Panel M527 K251526FilmArray GI Control Panel M238 K241289SPOTFIRE RSP Pos & Neg Controls; SPOTFIRE RSP Negative Control K233611SPOTFIRE RSP Pos & Neg Controls (M425), SPOTFIRE RSP Positive Control (M42638), SPOTFIRE RSP Negative Control (M42738)K230868SPOTFIRE® RSP Pos & Neg Controls, SPOTFIRE® RSP Positive Control, SPOTFIRE® RSP Negative Control K221253SPOTFIRE RSP Positive Control, SPOTFIRE RSP Negative Control

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Dispositivos relacionados (Código: PMN)

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Fuente oficial

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