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

    ACA DU PONT METHOTREXATE (MTHO) METHOD

    K Number: K884744 · Decision Jan 30, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4
    Same Product Code
    9
    Applicant Total
    253
    Review Days
    77

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    Basic Information

    Device Name
    ACA DU PONT METHOTREXATE (MTHO) METHOD
    K Number
    K884744
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Applicant
    E.I. Dupont DE Nemours & Co., Inc.
    Date Received
    November 14, 1988
    Decision Date
    January 30, 1989
    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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