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

    J&S PEDIATRIC IRON SATURATING REAGENT

    K Number: K910672 · Decision Apr 29, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Same Product Code
    5
    Applicant Total
    18
    Review Days
    73

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    Basic Information

    Device Name
    J&S PEDIATRIC IRON SATURATING REAGENT
    K Number
    K910672
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.1415
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    J.S. Medical Assoc.
    Date Received
    February 15, 1991
    Decision Date
    April 29, 1991
    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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