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

    TOTAL IRON BINDING CAPACITY

    K Number: K780412 · Decision May 26, 1978
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    4
    Applicant Total
    3
    Review Days
    72

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    Basic Information

    Device Name
    TOTAL IRON BINDING CAPACITY
    K Number
    K780412
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.1415
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Diagnostic Corp. of America
    Date Received
    March 15, 1978
    Decision Date
    May 26, 1978
    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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    Other Clearances by Diagnostic Corp. of America

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