BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    TIBC PRETREATMENT KIT

    K Number: K842019 · Decision Jun 22, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Same Product Code
    5
    Applicant Total
    253
    Review Days
    35

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    Basic Information

    Device Name
    TIBC PRETREATMENT KIT
    K Number
    K842019
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.1415
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    E.I. Dupont DE Nemours & Co., Inc.
    Date Received
    May 18, 1984
    Decision Date
    June 22, 1984
    Product Code
    JQE
    Advisory Committee
    Clinical Chemistry
    Review Advisory Committee
    CH
    Third Party
    N

    Classifications

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

    Product Code Device Name
    JQE Resin, Ion-Exchange, Ascorbic Acid, Colorimetry, Iron Binding Capacity

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