BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Immunohistochemistry Antibody Assay, C-Kit

    PMA: P020055 · Supplement: S002 · Decision Sep 27, 2011
    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
    S002
    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
    September 27, 2011
    Date Received
    May 23, 2011
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE ADDITION OF A STRAINER TYPE BARRIER TO THE CURRENT DAB DISPENSER RETAINER DESIGN, COLORIZATION OF STOP BARREL, AND ASSEMBLY EQUIPMENT UPDATES TO ACCOMMODATE THE MODIFIED RETAINER.

    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