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510(k) Data Aggregation

    K Number
    K012855
    Device Name
    LIQUISPX LIQUID LIPID CONTROL
    Date Cleared
    2001-08-30

    (6 days)

    Product Code
    Regulation Number
    862.1660
    Why did this record match?
    Applicant Name (Manufacturer) :

    CLINICAL CONTROLS DIVISION

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Clinical Controls LiquiSPx Liquid Lipid control is a ready-to-use, assayed chemistry control material for monitoring the accuracy and precision of lipid chemistry control material for monitoring the automated analytical procedures. Lipid analysis consists of measuring total cholesterol, triglycerides, HDL and LDL cholesterol. It is used to assist in the diagnosis and management of LDL cholesterol. This dood to assist in tisk patient populations.
    Device Description
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