BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    System, Test, Her-2/Neu, Ihc

    PMA: P090015 · Supplement: S001 · Decision Feb 11, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    7
    Registration Numbers
    7

    Basic Information

    Device Name
    System, Test, Her-2/Neu, Ihc
    Trade Name
    BOND ORACLE HER2 IHC SYSTEM
    PMA Number
    P090015
    Supplement Number
    S001
    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
    February 11, 2014
    Date Received
    July 26, 2013
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE MANUFACTURING CHANGES TO THE BOND-MAX SOFTWARE, INSTRUMENT STYLING AND USABILITY, THE REAGENT AND BOND-MAX INSTRUMENT MANUFACTURING PROCESSES, AND ASSOCIATED LABELING CHANGES.

    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