FDA 510(k)

BioFire RP2.1/RP2.1plus Control Panel M441

Número K: K202196 · 2021-06-24

RequerenteMaine Molecular Quality Controls, Inc.

Data da decisão2021-06-24

Código do produtoPMN

Comité consultivoMI

DecisãoSubstantially Equivalent

Resumo do dispositivo

BioFire RP2.1/RP2.1plus Control Panel M441 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 2021-06-24 under 510(k) number K202196. 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 BioFire RP2.1/RP2.1plus Control Panel M441?

BioFire RP2.1/RP2.1plus Control Panel M441 is a medical device that received FDA 510(k) clearance on 2021-06-24. The listed applicant is Maine Molecular Quality Controls, Inc.. The 510(k) number is K202196.

When did BioFire RP2.1/RP2.1plus Control Panel M441 receive FDA 510(k) clearance?

BioFire RP2.1/RP2.1plus Control Panel M441 received FDA 510(k) clearance on 2021-06-24, under 510(k) number K202196.

Who is the listed applicant for BioFire RP2.1/RP2.1plus Control Panel M441?

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 BioFire RP2.1/RP2.1plus Control Panel M441?

The FDA product code for BioFire RP2.1/RP2.1plus Control Panel M441 is PMN.

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Fonte oficial

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