FDA 510(k)

xTAG Gastrointestinal Pathogen Panel (GPP), xTAG Data Analysis Software (TDAS GPP)

N.º K: K191160 · 2019-11-04

SolicitanteLuminex Molecular Diagnostics, Inc.

Fecha de decisión2019-11-04

Código de productoPCH

Comité asesorMI

DecisiónSubstantially Equivalent

Resumen del dispositivo

xTAG Gastrointestinal Pathogen Panel (GPP), xTAG Data Analysis Software (TDAS GPP) is the device name listed in this FDA 510(k) record. The listed applicant is Luminex Molecular Diagnostics, Inc.. It received FDA 510(k) clearance on 2019-11-04 under 510(k) number K191160. The device is classified under product code PCH. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the xTAG Gastrointestinal Pathogen Panel (GPP), xTAG Data Analysis Software (TDAS GPP)?

xTAG Gastrointestinal Pathogen Panel (GPP), xTAG Data Analysis Software (TDAS GPP) is a medical device that received FDA 510(k) clearance on 2019-11-04. The listed applicant is Luminex Molecular Diagnostics, Inc.. The 510(k) number is K191160.

When did xTAG Gastrointestinal Pathogen Panel (GPP), xTAG Data Analysis Software (TDAS GPP) receive FDA 510(k) clearance?

xTAG Gastrointestinal Pathogen Panel (GPP), xTAG Data Analysis Software (TDAS GPP) received FDA 510(k) clearance on 2019-11-04, under 510(k) number K191160.

Who is the listed applicant for xTAG Gastrointestinal Pathogen Panel (GPP), xTAG Data Analysis Software (TDAS GPP)?

The FDA 510(k) record lists Luminex Molecular Diagnostics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for xTAG Gastrointestinal Pathogen Panel (GPP), xTAG Data Analysis Software (TDAS GPP)?

The FDA product code for xTAG Gastrointestinal Pathogen Panel (GPP), xTAG Data Analysis Software (TDAS GPP) is PCH.

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Otros registros que enlistan a Luminex Molecular Diagnostics, Inc. como solicitante

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Fuente oficial

Ver en la base de datos de la FDA →

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