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

    CANTROL SERUM IRON AND TOTAL IRON BINDING CAPACITY TEST SYSTEM

    K Number: K970248 · Decision Feb 11, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Same Product Code
    5
    Applicant Total
    9
    Review Days
    20

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    Basic Information

    Device Name
    CANTROL SERUM IRON AND TOTAL IRON BINDING CAPACITY TEST SYSTEM
    K Number
    K970248
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.1415
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Canyon Diagnostics, Inc.
    Date Received
    January 22, 1997
    Decision Date
    February 11, 1997
    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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