BEUDAMED
    FDA PMA FDA Class 3 30-Day Notice Accepted 🇺🇸 United States

    Immunohistochemistry Assay, Antibody, Anaplastic Lymphoma Kinase

    PMA: P140025 · Supplement: S021 · Decision Aug 29, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1

    Basic Information

    Device Name
    Immunohistochemistry Assay, Antibody, Anaplastic Lymphoma Kinase
    Trade Name
    VENTANA ALK (D5F3) CDx Assay
    PMA Number
    P140025
    Supplement Number
    S021
    Device Class
    FDA Class 3
    Product Code
    PKW
    Generic Name
    Immunohistochemistry assay, antibody, anaplastic lymphoma kinase
    Medical Specialty
    Unknown
    Advisory Committee
    Pathology
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    August 29, 2023
    Date Received
    August 1, 2023
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    Addition of two contract manufacturers as approved suppliers of parts/components.

    Classifications

    This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    PKW Immunohistochemistry Assay, Antibody, Anaplastic Lymphoma Kinase