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

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

    PMA: P050045 · Supplement: S002 · Decision Mar 26, 2008
    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 PHARMDX
    PMA Number
    P050045
    Supplement Number
    S002
    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
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    March 26, 2008
    Date Received
    March 6, 2008
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    CHANGE IN AUXILIARY MATERIAL/SUPPLIER USED IN THE PRODUCTION OF THE PROBE MIX TO ELIMINATE ENZYME RELATED STABILITY PROBLEMS.

    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