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

    Immunohistochemistry Assay, Antibody, Epidermal Growth Factor Receptor

    PMA: P030044 · Supplement: S004 · Decision Jan 22, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Device Name
    Immunohistochemistry Assay, Antibody, Epidermal Growth Factor Receptor
    Trade Name
    EGFR pharmDx
    PMA Number
    P030044
    Supplement Number
    S004
    Device Class
    FDA Class 3
    Product Code
    NQF
    Generic Name
    Immunohistochemistry assay, antibody, epidermal growth factor receptor
    Regulation Number
    864.1860
    Medical Specialty
    Hematology
    Advisory Committee
    Pathology
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    January 22, 2018
    Date Received
    December 26, 2017
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    Changed manufacturing process (order of addition) of components in two diluent solutions.

    Classifications

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

    Product Code Device Name
    NQF Immunohistochemistry Assay, Antibody, Epidermal Growth Factor Receptor