BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Immunohistochemistry Antibody Assay, C-Kit

    PMA: P020055 · Supplement: S008 · Decision Jul 25, 2013
    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
    S008
    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
    July 25, 2013
    Date Received
    May 6, 2013
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR MINOR MODIFICATIONS TO THE DESIGN OF THE DISPENSER INWHICH THE PMA REAGENTS IN THE DEVICES ARE STORED AND OR USED, INCLUDING A CHANGE IN THE MATERIALS THE VARIOUS DISPENSER PARTS ARE MADE FROM.

    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