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FDA 510(k)

xTAG Gastrointestinal Pathogen Panel (GPP)

K-Number: K191161 · 2019-11-12

ApplicantLuminex Molecular Diagnostics, Inc.
Decision Date2019-11-12
Product CodePCH
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

xTAG Gastrointestinal Pathogen Panel (GPP) is a medical device manufactured by Luminex Molecular Diagnostics, Inc.. It received FDA 510(k) clearance on 2019-11-12 under approval number K191161. The device is classified under product code PCH. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the xTAG Gastrointestinal Pathogen Panel (GPP)?

xTAG Gastrointestinal Pathogen Panel (GPP) is a medical device that received FDA 510(k) clearance on 2019-11-12. It is manufactured by Luminex Molecular Diagnostics, Inc.. The 510(k) number is K191161.

When was xTAG Gastrointestinal Pathogen Panel (GPP) approved by the FDA?

xTAG Gastrointestinal Pathogen Panel (GPP) received FDA 510(k) clearance on 2019-11-12, under approval number K191161.

What company makes xTAG Gastrointestinal Pathogen Panel (GPP)?

xTAG Gastrointestinal Pathogen Panel (GPP) is manufactured by Luminex Molecular Diagnostics, Inc..

What is the FDA product code for xTAG Gastrointestinal Pathogen Panel (GPP)?

The FDA product code for xTAG Gastrointestinal Pathogen Panel (GPP) is PCH.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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