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

    TOTAL IRON BINDING CAPACITY TEST

    K Number: K830032 · Decision Jan 28, 1983
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    7
    Applicant Total
    82
    Review Days
    21

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    Basic Information

    Device Name
    TOTAL IRON BINDING CAPACITY TEST
    K Number
    K830032
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.1415
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Sclavo, Inc.
    Date Received
    January 7, 1983
    Decision Date
    January 28, 1983
    Product Code
    JQF
    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
    JQF Bathophenanthroline, Iron Binding Capacity

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