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

    PMA: P200014 · Supplement: S004 · Decision Nov 29, 2022
    View on FDA
    Classifications
    0
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Trade Name
    cobas® EZH2 Mutation Test
    PMA Number
    P200014
    Supplement Number
    S004
    Advisory Committee
    Pathology
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    November 29, 2022
    Date Received
    October 18, 2022
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    Discontinuation of redundant pH testing for vialed Paraffin Binding Buffer.