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

    EMIT METHATREXATE ASSAY

    K Number: K781381 · Decision Oct 10, 1978
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4
    Same Product Code
    9
    Applicant Total
    343
    Review Days
    60

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    Basic Information

    Device Name
    EMIT METHATREXATE ASSAY
    K Number
    K781381
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Applicant
    Dade Behring, Inc.
    Date Received
    August 11, 1978
    Decision Date
    October 10, 1978
    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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