BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    System, Test, Her-2/Neu, Ihc

    PMA: P980018 · Decision Sep 25, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    7
    Registration Numbers
    7

    Basic Information

    Device Name
    System, Test, Her-2/Neu, Ihc
    Trade Name
    DAKO HERCEPTEST
    PMA Number
    P980018
    Device Class
    FDA Class 3
    Product Code
    MVC
    Generic Name
    SYSTEM, TEST, HER-2/NEU, IHC
    Medical Specialty
    Unknown
    Advisory Committee
    Pathology
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    September 25, 1998
    Date Received
    May 18, 1998
    Expedited Review
    N
    Docket Number
    98M-0857

    Advisory Committee Statement

    Approval for the DAKO Herceptest. This device is a semi-quantitative immunohistochemical assay to determine HER2 overexpression in breast cancer tissues routinely processed for histological evaluation. HercepTest is indicated as an aid in the assessment of patients for whom HERCEPTIN(R)(Transtuzumab) treatment is being considered.

    Classifications

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

    Product Code Device Name
    MVC System, Test, Her-2/Neu, Ihc