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

    Immunohistochemistry Assay, Antibody, Melanoma-Associated Antigen A4

    PMA: P230016 · Supplement: S002 · Decision Jun 27, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3

    Basic Information

    Device Name
    Immunohistochemistry Assay, Antibody, Melanoma-Associated Antigen A4
    Trade Name
    MAGE-A4 IHC 1F9 pharmDx
    PMA Number
    P230016
    Supplement Number
    S002
    Device Class
    FDA Class 3
    Product Code
    SBL
    Generic Name
    Immunohistochemistry Assay, Antibody, Melanoma-associated antigen A4
    Regulation Number
    864.1860
    Medical Specialty
    Hematology
    Advisory Committee
    Pathology
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    June 27, 2025
    Date Received
    April 16, 2025
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    approval for incorporating a fill-volume tolerance range and software into a vial-filling process

    Classifications

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

    Product Code Device Name
    SBL Immunohistochemistry Assay, Antibody, Melanoma-Associated Antigen A4