BEUDAMED
    FDA PMA Approved 🇺🇸 United States

    PMA: P190014 · Supplement: S008 · Decision Oct 27, 2023
    View on FDA
    Classifications
    0
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Trade Name
    MyChoice® CDx
    PMA Number
    P190014
    Supplement Number
    S008
    Advisory Committee
    Pathology
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    October 27, 2023
    Date Received
    January 20, 2023
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    Approval to replace the Illumina HiSeq 2500 Sequencer with the Illumina Next-generation Sequencer (NovaSeq 6000) for MyChoice CDx device.