FDA 510(k)

SPOTFIRE RSP Positive Control, SPOTFIRE RSP Negative Control

Número K: K221253 · 2023-02-03

RequerenteMaine Molecular Quality Controls, Inc.

Data da decisão2023-02-03

Código do produtoPMN

Comité consultivoMI

DecisãoSubstantially Equivalent

Resumo do dispositivo

SPOTFIRE RSP Positive Control, SPOTFIRE RSP Negative 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 2023-02-03 under 510(k) number K221253. 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 SPOTFIRE RSP Positive Control, SPOTFIRE RSP Negative Control?

SPOTFIRE RSP Positive Control, SPOTFIRE RSP Negative Control is a medical device that received FDA 510(k) clearance on 2023-02-03. The listed applicant is Maine Molecular Quality Controls, Inc.. The 510(k) number is K221253.

When did SPOTFIRE RSP Positive Control, SPOTFIRE RSP Negative Control receive FDA 510(k) clearance?

SPOTFIRE RSP Positive Control, SPOTFIRE RSP Negative Control received FDA 510(k) clearance on 2023-02-03, under 510(k) number K221253.

Who is the listed applicant for SPOTFIRE RSP Positive Control, SPOTFIRE RSP Negative 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 SPOTFIRE RSP Positive Control, SPOTFIRE RSP Negative Control?

The FDA product code for SPOTFIRE RSP Positive Control, SPOTFIRE RSP Negative Control is PMN.

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

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 K203680BioFire JI Control Panel M420

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Fonte oficial

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