FDA 510(k)

SPOTFIRE® RSP Pos & Neg Controls, SPOTFIRE® RSP Positive Control, SPOTFIRE® RSP Negative Control

Número K: K230868 · 2023-04-13

RequerenteMaine Molecular Quality Controls, Inc.

Data da decisão2023-04-13

Código do produtoPMN

Comité consultivoMI

DecisãoSubstantially Equivalent

Resumo do dispositivo

SPOTFIRE® RSP Pos & Neg Controls, 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 2023-04-13 under 510(k) number K230868. 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 Pos & Neg Controls, SPOTFIRE® RSP Positive Control, SPOTFIRE® RSP Negative Control?

SPOTFIRE® RSP Pos & Neg Controls, SPOTFIRE® RSP Positive Control, SPOTFIRE® RSP Negative Control is a medical device that received FDA 510(k) clearance on 2023-04-13. The listed applicant is Maine Molecular Quality Controls, Inc.. The 510(k) number is K230868.

When did SPOTFIRE® RSP Pos & Neg Controls, SPOTFIRE® RSP Positive Control, SPOTFIRE® RSP Negative Control receive FDA 510(k) clearance?

SPOTFIRE® RSP Pos & Neg Controls, SPOTFIRE® RSP Positive Control, SPOTFIRE® RSP Negative Control received FDA 510(k) clearance on 2023-04-13, under 510(k) number K230868.

Who is the listed applicant for SPOTFIRE® RSP Pos & Neg Controls, 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 Pos & Neg Controls, SPOTFIRE® RSP Positive Control, SPOTFIRE® RSP Negative Control?

The FDA product code for SPOTFIRE® RSP Pos & Neg Controls, 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)

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Fonte oficial

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