BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Fluorescence In Situ Hybridization, Topoisomerase Ii Alpha, Gene Amplification And Deletion

    PMA: P050045 · Supplement: S004 · Decision Jun 1, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Device Name
    Fluorescence In Situ Hybridization, Topoisomerase Ii Alpha, Gene Amplification And Deletion
    Trade Name
    TOP2A FISH PHARMADX KIT
    PMA Number
    P050045
    Supplement Number
    S004
    Device Class
    FDA Class 3
    Product Code
    NXG
    Generic Name
    Fluorescence in situ hybridization, topoisomerase ii alpha, gene amplification and deletion
    Medical Specialty
    Unknown
    Advisory Committee
    Pathology
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    June 1, 2012
    Date Received
    December 23, 2011
    Supplement Type
    135 Review Track For 30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE MANUFACTURING PROCESS OF PMA OLIGOMERS IN THE DEVICE.

    Classifications

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

    Product Code Device Name
    NXG Fluorescence In Situ Hybridization, Topoisomerase Ii Alpha, Gene Amplification And Deletion