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

    Fluorescence In Situ Hybridization, Chromosome 17p Deletion (Tp53)

    PMA: P150041 · Supplement: S004 · Decision Aug 29, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1

    Basic Information

    Device Name
    Fluorescence In Situ Hybridization, Chromosome 17p Deletion (Tp53)
    Trade Name
    Vysis CLL FISH Probe Kit
    PMA Number
    P150041
    Supplement Number
    S004
    Device Class
    FDA Class 3
    Product Code
    PNK
    Generic Name
    Fluorescence in situ hybridization, chromosome 17p deletion (TP53)
    Medical Specialty
    Unknown
    Advisory Committee
    Pathology
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    August 29, 2018
    Date Received
    August 10, 2018
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    QC/manufacturing equipment changes and DNA Ladder changes.

    Classifications

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

    Product Code Device Name
    PNK Fluorescence In Situ Hybridization, Chromosome 17p Deletion (Tp53)