BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Immunohistochemistry Assay, Antibody, Met

    PMA: P240037 · Supplement: S001 · Decision Jul 11, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1

    Basic Information

    Device Name
    Immunohistochemistry Assay, Antibody, Met
    Trade Name
    VENTANA MET (SP44) RxDx Assay
    PMA Number
    P240037
    Supplement Number
    S001
    Device Class
    FDA Class 3
    Product Code
    SER
    Generic Name
    Immunohistochemistry Assay, Antibody, MET
    Regulation Number
    864.1860
    Medical Specialty
    Hematology
    Advisory Committee
    Pathology
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    July 11, 2025
    Date Received
    June 11, 2025
    Supplement Type
    Normal 180 Day Track No User Fee
    Supplement Reason
    Postapproval Study Protocol
    Expedited Review
    N

    Advisory Committee Statement

    Approval of the clinical protocol titled Prevalence and Efficacy Assessment for VENTANA MET (SP44) RxDx Assay by the Different Cellular Compartments, for the post-approval study (PAS) protocol.

    Classifications

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

    Product Code Device Name
    SER Immunohistochemistry Assay, Antibody, Met