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FDA 510(k)

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

K-Number: K183030 · 2018-11-30

ApplicantLuminex Molecular Diagnostics, Inc.
Decision Date2018-11-30
Product CodePCH
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

xTAG Gastrointestinal Pathogen Panel (GPP), xTAG Data Analysis Software (TDAS GPP) is a medical device manufactured by Luminex Molecular Diagnostics, Inc.. It received FDA 510(k) clearance on 2018-11-30 under approval number K183030. 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 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. It is manufactured by Luminex Molecular Diagnostics, Inc.. The 510(k) number is K183030.

When was xTAG Gastrointestinal Pathogen Panel (GPP), xTAG Data Analysis Software (TDAS GPP) approved by the FDA?

xTAG Gastrointestinal Pathogen Panel (GPP), xTAG Data Analysis Software (TDAS GPP) received FDA 510(k) clearance on 2018-11-30, under approval number K183030.

What company makes xTAG Gastrointestinal Pathogen Panel (GPP), xTAG Data Analysis Software (TDAS GPP)?

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

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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Related PubMed Literature

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Other Devices by Luminex Molecular Diagnostics, Inc.

K163347xTAG Cystic Fibrosis 39 Kit v2 K163336xTAG Cystic Fibrosis 60 Kit v2, xTAG Data Analysis Software (TDAS) CFTR K170492xTAG CYP2D6 Kit v3 K183023xTAG Gastrointestinal Pathogen Panel (GPP), xTAG Data Analysis Software (TDAS GPP) K193167NxTAG Respiratory Pathogen Panel, NxTAG Respiratory Pathogen Panel Files, SYNCT Software K191161xTAG Gastrointestinal Pathogen Panel (GPP)

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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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