BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Immunohistochemistry Assay, Antibody, Anaplastic Lymphoma Kinase

    PMA: P140025 · Supplement: S013 · Decision Nov 13, 2020
    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
    S013
    Device Class
    FDA Class 3
    Product Code
    PKW
    Generic Name
    Immunohistochemistry assay, antibody, anaplastic lymphoma kinase
    Medical Specialty
    Unknown
    Advisory Committee
    Pathology
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    November 13, 2020
    Date Received
    August 26, 2020
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    Approval for the replacement of dispenser molds used in the injection molding process for six (6) dispenser parts.

    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