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

    TRIGLYERIDES TEST KIT

    K Number: K874584 · Decision Jan 21, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    39
    Registration Numbers
    39
    Same Product Code
    150
    Applicant Total
    125
    Review Days
    73

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    Basic Information

    Device Name
    TRIGLYERIDES TEST KIT
    K Number
    K874584
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.1705
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Ciba Corning Diagnostics Corp.
    Date Received
    November 9, 1987
    Decision Date
    January 21, 1988
    Product Code
    CDT
    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
    CDT Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides

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