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

    System, Test, Her-2/Neu, Ihc

    PMA: P980018 · Supplement: S019 · Decision May 21, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    7
    Registration Numbers
    7

    Basic Information

    Device Name
    System, Test, Her-2/Neu, Ihc
    Trade Name
    HERCEP TEST
    PMA Number
    P980018
    Supplement Number
    S019
    Device Class
    FDA Class 3
    Product Code
    MVC
    Generic Name
    SYSTEM, TEST, HER-2/NEU, IHC
    Medical Specialty
    Unknown
    Advisory Committee
    Pathology
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    May 21, 2015
    Date Received
    April 27, 2015
    Supplement Type
    30-Day Notice
    Expedited Review
    N

    Advisory Committee Statement

    MODIFY THE IN PROCESS QUALITY CONTROL (IPC) TEST TO VERIFY THE PERFORMANCE OF BULK REAGENTS (INTERMEDIATES) DAB+ BUFFERED SUBSTRATE AND DAB+ CHROMOGEN.

    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