BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    DU PONT ACA METHOTREXATE CALIBRATOR

    K Number: K884745 · Decision Jan 30, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    40
    Registration Numbers
    40
    Same Product Code
    122
    Applicant Total
    253
    Review Days
    77

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    Basic Information

    Device Name
    DU PONT ACA METHOTREXATE CALIBRATOR
    K Number
    K884745
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3200
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Applicant
    E.I. Dupont DE Nemours & Co., Inc.
    Date Received
    November 14, 1988
    Decision Date
    January 30, 1989
    Product Code
    DLJ
    Advisory Committee
    Clinical Toxicology
    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
    DLJ Calibrators, Drug Specific

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