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

    PMA: P140023 · Supplement: S024 · Decision Nov 29, 2022
    View on FDA
    Classifications
    0
    FEI Numbers
    0
    Registration Numbers
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    Basic Information

    Trade Name
    cobas® KRAS Mutation Test
    PMA Number
    P140023
    Supplement Number
    S024
    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.