FDA 510(k)

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

Numéro K : K183023 · 2018-11-30

DemandeurLuminex Molecular Diagnostics, Inc.

Date de décision2018-11-30

Code produitPCH

Comité consultatifMI

DécisionSubstantially Equivalent

Résumé du dispositif

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 2018-11-30 under 510(k) number K183023. The device is classified under product code PCH. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

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 2018-11-30. The listed applicant is Luminex Molecular Diagnostics, Inc.. The 510(k) number is K183023.

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 2018-11-30, under 510(k) number K183023.

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.

Essais cliniques associés

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Dispositifs connexes (Code : PCH)

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Source officielle

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