BEUDAMED
    FDA 510(k) FDA unclassified Substantially Equivalent 🇺🇸 United States

    ONLINE TDM Methotrexate

    K Number: K233454 · Decision Feb 20, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4
    Same Product Code
    9
    Applicant Total
    5
    Review Days
    123

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    Basic Information

    Device Name
    ONLINE TDM Methotrexate
    K Number
    K233454
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Roche Diagnostics Operations
    Date Received
    October 20, 2023
    Decision Date
    February 20, 2024
    Product Code
    LAO
    Advisory Committee
    Unknown
    Review Advisory Committee
    TX
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    LAO Enzyme Immunoassay, Methotrexate

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