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    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?
    Applicant Name (Manufacturer) :

    LIFESTREAM TECHNOLOGIES, INC.

    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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    K Number
    K000610
    Device Name
    RESOLUTION CHOLESTEROL MONITOR
    Manufacturer
    LIFESTREAM TECHNOLOGIES, INC.
    Date Cleared
    2000-07-21

    (149 days)

    Product Code
    CHH
    Regulation Number
    862.1175
    Why did this record match?
    Applicant Name (Manufacturer) :

    LIFESTREAM TECHNOLOGIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K993096
    Device Name
    PRIVALINK SOFTWARE ACCESSORY TO THE LIFESTREAM CHOLESTEROL MONITOR
    Manufacturer
    LIFESTREAM TECHNOLOGIES, INC.
    Date Cleared
    1999-12-20

    (206 days)

    Product Code
    CHH
    Regulation Number
    862.1175
    Why did this record match?
    Applicant Name (Manufacturer) :

    LIFESTREAM TECHNOLOGIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    INTENDED USE The Lifestream Cholesterol Monitor is a professional-use, point-of-care in vitro diagnostic device for the measurement of total cholesterol in fingerstick whole blood samples, used with the Privalink Software accessory to provide personalized health related information INDICATIONS FOR USE Total cholesterol measurements aid in the detection of persons who may be at risk for coronary heart disease, and with personalized health related information, aid in the management of patients undergoing therapy with lipid lowering drugs. The measurement range for the Cholestron is 150 - 300 mg/dL. Prescription Use
    Device Description
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