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

    KENLOR TOTAL IRON, UIBC/TIBC ASSAY KIT

    K Number: K890573 · Decision Mar 24, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    35
    Registration Numbers
    35
    Same Product Code
    66
    Applicant Total
    9
    Review Days
    46

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    Basic Information

    Device Name
    KENLOR TOTAL IRON, UIBC/TIBC ASSAY KIT
    K Number
    K890573
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.1410
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Kenlor Industries, Inc.
    Date Received
    February 6, 1989
    Decision Date
    March 24, 1989
    Product Code
    JIY
    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
    JIY Photometric Method, Iron (Non-Heme)

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