BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇦🇺 Australia

    ALFERR TIBC TUBE

    K Number: K864548 · Decision Feb 2, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Same Product Code
    5
    Applicant Total
    1
    Review Days
    75

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    Basic Information

    Device Name
    ALFERR TIBC TUBE
    K Number
    K864548
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.1415
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Benchmark Reagents
    Date Received
    November 19, 1986
    Decision Date
    February 2, 1987
    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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