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510(k) Data Aggregation

    K Number
    K981345
    Device Name
    CHOLESTRON PRO II CHOLESTEROL TEST
    Manufacturer
    LIFESTREAM DIAGNOSTICS, INC.
    Date Cleared
    1998-10-01

    (170 days)

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

    LIFESTREAM DIAGNOSTICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Cholestron™ Pro II Cholesterol Test (Cholestron) is a professional-use, point-ofcare 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 aid in the management of patients undergoing therapy with lipid lowering drugs. The measurement range for the Cholestron is 150 - 300 mg/dL.
    Device Description
    The Cholestron system consists of a photometer with a display assembly keypad, and single-use, disposable reagent strips. Fingerstick whole blood is applied directly to the device, and cholesterol results are available in approximately three minutes.
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