BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇦 Canada

    xTAG Gastrointestinal Pathogen Panel (GPP)

    K Number: K191161 · Decision Nov 12, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    14
    Registration Numbers
    14
    Same Product Code
    31
    Applicant Total
    10
    Review Days
    195

    Basic Information

    Device Name
    xTAG Gastrointestinal Pathogen Panel (GPP)
    K Number
    K191161
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    866.3990
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Luminex Molecular Diagnostics, Inc.
    Date Received
    May 1, 2019
    Decision Date
    November 12, 2019
    Product Code
    PCH
    Advisory Committee
    Microbiology
    Review Advisory Committee
    MI
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    PCH Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System

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    Other Clearances by Luminex Molecular Diagnostics, Inc.

    K Number Device Name
    K242613 NxTAG® Respiratory Pathogen Panel
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    K193167 NxTAG Respiratory Pathogen Panel, NxTAG Respiratory Pathogen Panel Files, SYNCT Software
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    K183023 xTAG Gastrointestinal Pathogen Panel (GPP), xTAG Data Analysis Software (TDAS GPP)
    K183030 xTAG Gastrointestinal Pathogen Panel (GPP), xTAG Data Analysis Software (TDAS GPP)
    K170492 xTAG CYP2D6 Kit v3
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    K163336 xTAG Cystic Fibrosis 60 Kit v2, xTAG Data Analysis Software (TDAS) CFTR