BEUDAMED
    FDA 510(k) FDA class 2 Unknown 🇨🇦 Canada

    xTAG Cystic Fibrosis 60 Kit v2, xTAG Data Analysis Software (TDAS) CFTR

    K Number: K163336 · Decision Dec 15, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Same Product Code
    11
    Applicant Total
    10
    Review Days
    17

    Basic Information

    Device Name
    xTAG Cystic Fibrosis 60 Kit v2, xTAG Data Analysis Software (TDAS) CFTR
    K Number
    K163336
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    866.5900
    Medical Specialty
    Immunology
    Decision
    Unknown
    Statement or Summary
    Statement
    Applicant
    Luminex Molecular Diagnostics, Inc.
    Date Received
    November 28, 2016
    Decision Date
    December 15, 2016
    Product Code
    NUA
    Advisory Committee
    Immunology
    Review Advisory Committee
    MG
    Third Party
    N

    Classifications

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

    Product Code Device Name
    NUA System, Cystic Fibrosis Transmembrane Conductance Regulator, Gene Mutation Detection

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    Other Clearances by Luminex Molecular Diagnostics, Inc.

    K Number Device Name
    K242613 NxTAG® Respiratory Pathogen Panel
    K231758 NxTAG Respiratory Pathogen Panel v2 (NxTAG RPP v2)
    K193167 NxTAG Respiratory Pathogen Panel, NxTAG Respiratory Pathogen Panel Files, SYNCT Software
    K191161 xTAG Gastrointestinal Pathogen Panel (GPP)
    K191160 xTAG Gastrointestinal Pathogen Panel (GPP), xTAG Data Analysis Software (TDAS GPP)
    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
    K163347 xTAG Cystic Fibrosis 39 Kit v2