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

    NxTAG® Respiratory Pathogen Panel

    K Number: K242613 · Decision Oct 2, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    29
    Registration Numbers
    29
    Same Product Code
    77
    Applicant Total
    10
    Review Days
    29

    Basic Information

    Device Name
    NxTAG® Respiratory Pathogen Panel
    K Number
    K242613
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    866.3980
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Luminex Molecular Diagnostics, Inc.
    Date Received
    September 3, 2024
    Decision Date
    October 2, 2024
    Product Code
    OCC
    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
    OCC Respiratory Virus Panel Nucleic Acid Assay System

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    Other Clearances by Luminex Molecular Diagnostics, Inc.

    K Number Device Name
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