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

    KODAK EKTACHEM TOTAL IRON-BINDING CAPACITY KIT

    K Number: K931493 · Decision May 26, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    34
    Registration Numbers
    34
    Same Product Code
    45
    Applicant Total
    238
    Review Days
    62

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    Basic Information

    Device Name
    KODAK EKTACHEM TOTAL IRON-BINDING CAPACITY KIT
    K Number
    K931493
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.1415
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Eastman Kodak Company
    Date Received
    March 25, 1993
    Decision Date
    May 26, 1993
    Product Code
    JMO
    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
    JMO Ferrozine (Colorimetric) Iron Binding Capacity

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