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    K Number
    K120202
    Device Name
    EON CHOLESTEROL REAGENT
    Manufacturer
    VITAL DIAGNOSTICS PTY. LTD
    Date Cleared
    2012-07-27

    (186 days)

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

    VITAL DIAGNOSTICS PTY. LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Eon Cholesterol Reagent is an in vitro diagnostic device intended for the quantitative determination of total cholesterol in human plasma and serum using the Eon 100 Clinical Chemistry Analyser. Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipid and lipoprotein metabolism disorders.
    Device Description
    Not Found
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