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

    Immunohistochemistry Antibody Assay, C-Kit

    PMA: P020055 · Supplement: S016 · Decision Dec 4, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2

    Basic Information

    Device Name
    Immunohistochemistry Antibody Assay, C-Kit
    Trade Name
    PATHWAY ANTI-C-KIT (9.7) RABBIT MONOCLONAL PRIMARY ANTIBODY
    PMA Number
    P020055
    Supplement Number
    S016
    Device Class
    FDA Class 3
    Product Code
    NKF
    Generic Name
    Immunohistochemistry antibody assay, c-kit
    Regulation Number
    864.1860
    Medical Specialty
    Hematology
    Advisory Committee
    Pathology
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    December 4, 2014
    Date Received
    October 27, 2014
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    CHANGE IN THE MANUFACTURING PARAMETERS FOR THE VENTANA REAGENT DISPENSER VENT SEAL.

    Classifications

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

    Product Code Device Name
    NKF Immunohistochemistry Antibody Assay, C-Kit