FDA 510(k)

SPOTFIRE RSP Pos & Neg Controls (M425), SPOTFIRE RSP Positive Control (M42638), SPOTFIRE RSP Negative Control (M42738)

N.º K: K233611 · 2024-03-26

SolicitanteMaine Molecular Quality Controls, Inc.

Fecha de decisión2024-03-26

Código de productoPMN

Comité asesorMI

DecisiónSubstantially Equivalent

Resumen del dispositivo

SPOTFIRE RSP Pos & Neg Controls (M425), SPOTFIRE RSP Positive Control (M42638), SPOTFIRE RSP Negative Control (M42738) 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 2024-03-26 under 510(k) number K233611. 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 SPOTFIRE RSP Pos & Neg Controls (M425), SPOTFIRE RSP Positive Control (M42638), SPOTFIRE RSP Negative Control (M42738)?

SPOTFIRE RSP Pos & Neg Controls (M425), SPOTFIRE RSP Positive Control (M42638), SPOTFIRE RSP Negative Control (M42738) is a medical device that received FDA 510(k) clearance on 2024-03-26. The listed applicant is Maine Molecular Quality Controls, Inc.. The 510(k) number is K233611.

When did SPOTFIRE RSP Pos & Neg Controls (M425), SPOTFIRE RSP Positive Control (M42638), SPOTFIRE RSP Negative Control (M42738) receive FDA 510(k) clearance?

SPOTFIRE RSP Pos & Neg Controls (M425), SPOTFIRE RSP Positive Control (M42638), SPOTFIRE RSP Negative Control (M42738) received FDA 510(k) clearance on 2024-03-26, under 510(k) number K233611.

Who is the listed applicant for SPOTFIRE RSP Pos & Neg Controls (M425), SPOTFIRE RSP Positive Control (M42638), SPOTFIRE RSP Negative Control (M42738)?

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 (M425), SPOTFIRE RSP Positive Control (M42638), SPOTFIRE RSP Negative Control (M42738)?

The FDA product code for SPOTFIRE RSP Pos & Neg Controls (M425), SPOTFIRE RSP Positive Control (M42638), SPOTFIRE RSP Negative Control (M42738) 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 K230868SPOTFIRE® RSP Pos & Neg Controls, SPOTFIRE® RSP Positive Control, SPOTFIRE® RSP Negative Control K221253SPOTFIRE RSP Positive Control, SPOTFIRE RSP Negative Control K203680BioFire JI Control Panel M420

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Dispositivos relacionados (Código: PMN)

K261475BIOFIRE® FILMARRAY® Tropical Fever Panel Control KitBiofire Defense, LLC K260577FilmArray TF Control Panel M527Maine Molecular Quality Controls, Inc.K260041MDx-Chex for BCPStreck, LLC K254166MDx-Chex for BCNStreck K254167MDx-Chex for BCYStreck, LLC K251526FilmArray GI Control Panel M238Maine Molecular Quality Controls, Inc.

Fuente oficial

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