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

    System, Test, Her-2/Neu, Ihc

    PMA: P990081 · Supplement: S022 · Decision Oct 2, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    7
    Registration Numbers
    7

    Basic Information

    Device Name
    System, Test, Her-2/Neu, Ihc
    Trade Name
    PATHWAY ANTI-HER-2/NEU (4B5) RABBIT MONOCLONAL PRIMARY ANTIBODY
    PMA Number
    P990081
    Supplement Number
    S022
    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
    October 2, 2013
    Date Received
    August 30, 2013
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    ADD A SUPPLIER (ROCHE, PENZBERG) OF A COMPONENT (STREPTAVIDIN HORSERADISH PEROXIDASE) FOR THE IVIEW DAB DETECTION KIT.

    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