BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Immunohistochemistry Antibody Assay, C-Kit

    PMA: P020055 · Supplement: S025 · Decision Jun 10, 2022
    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) Primary Antibody
    PMA Number
    P020055
    Supplement Number
    S025
    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
    Approved
    Decision Code
    APPR
    Decision Date
    June 10, 2022
    Date Received
    January 28, 2022
    Supplement Type
    135 Review Track For 30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    Approval for the addition of two new contract manufacturers as approved suppliers for component parts.

    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