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

    TOTAL IRON BINDING CAPACITY TEST

    K Number: K884649 · Decision Dec 14, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Same Product Code
    5
    Applicant Total
    82
    Review Days
    37

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    Basic Information

    Device Name
    TOTAL IRON BINDING CAPACITY TEST
    K Number
    K884649
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.1415
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Sclavo, Inc.
    Date Received
    November 7, 1988
    Decision Date
    December 14, 1988
    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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