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510(k) Data Aggregation

    K Number
    K982767
    Device Name
    RAICHEM HDL-CHOLESTEROL DIRECT REAGENT, HDL-CHOLESTEROL CALIBRATOR
    Manufacturer
    Date Cleared
    1998-09-21

    (46 days)

    Product Code
    Regulation Number
    862.1150
    Why did this record match?
    Applicant Name (Manufacturer) :

    RAICHEM

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Raichem HDL-Cholesterol Direct Reagent is intended for the quantitative determination of HDL-Cholesterol in serum or plasma. The Raichem HDL-Cholesterol Calibrator is intended to be used for the calibration of the Raichem HDL-Cholesterol Direct assay.
    Device Description
    The Raichem HDL-Cholesterol Direct test is based upon two sets of reaction sequences. In the first set of reactions Chylomicrons. VLDL selectively react with cholesterol esterase and are then eliminated from the reaction scheme. The addition of the second reagent causes the reaction of HDL-Cholesterol with cholesterol esterase and the subsequent production of color. The resultant increase in absorbance is directly proportional to the concentration of HDL-Cholesterol in the sample. The Raichem HDL-Cholesterol Calibrator is a serum calibrator used for the calibration of the Raichem HDL-Cholesterol Direct assay.
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