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

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

    PMA: P150041 · Supplement: S008 · Decision Feb 18, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Device Name
    Fluorescence In Situ Hybridization, Chromosome 17p Deletion (Tp53)
    Trade Name
    Vysis CLL FISH Probe Kit
    PMA Number
    P150041
    Supplement Number
    S008
    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
    February 18, 2026
    Date Received
    January 21, 2026
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    implementation of a secondary packaging process

    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)