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

    FERRO-QUANT TM FE 59 TEST KIT

    K Number: K800868 · Decision Apr 29, 1980
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    4
    Applicant Total
    92
    Review Days
    12

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    Basic Information

    Device Name
    FERRO-QUANT TM FE 59 TEST KIT
    K Number
    K800868
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.1415
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Mallinckrodt Critical Care
    Date Received
    April 17, 1980
    Decision Date
    April 29, 1980
    Product Code
    JQG
    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
    JQG Radiometric, Fe59, Iron Binding Capacity

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