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510(k) Data Aggregation

    K Number
    K033899
    Device Name
    LIFESTREAM PLUS CHOLESTEROL MONITOR, MODIFICATION TO RESOLUTION CHOLESTEROL MONITOR
    Manufacturer
    LIFESTREAM TECHNOLOGIES, INC.
    Date Cleared
    2004-05-20

    (155 days)

    Product Code
    NFX
    Regulation Number
    862.1175
    Why did this record match?
    Product Code :

    NFX

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Lifestream Cholesterol Monitor is an over-the-counter in vitro diagnostic device for the measurement of total cholesterol in fingerstick whole blood samples. Total cholesterol measurements aid in the detection of persons who may be at risk for coronary heart disease, and provide information for individuals who are attempting to lower their levels through diet and exercise, or who are under a physician's care with lipid lowering drugs.
    Device Description
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