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510(k) Data Aggregation

    K Number
    K000568
    Device Name
    HDL CHOLESTEROL PLUS
    Manufacturer
    ROCHE DIAGNOSTICS CORP.
    Date Cleared
    2000-08-04

    (164 days)

    Product Code
    LBT
    Regulation Number
    862.1475
    Why did this record match?
    Product Code :

    LBT

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K990250
    Device Name
    HYDRAGEL LDL/HDL CHOL DIRECT KIT-P.N. 4005, HYDRAGEL 7 LDL/HDL CHOL DIRECT KIT-P.N. 4103, HYDRAGEL LDL/HDL CHOL DIRECT 0
    Manufacturer
    MORAX
    Date Cleared
    1999-06-18

    (143 days)

    Product Code
    LBT, JHO, LBS
    Regulation Number
    862.1475
    Why did this record match?
    Product Code :

    LBT

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    HYDRAGEL LDL/HDL CHOL DIRECT, HYDRAGEL 7 LDL/HDL CHOL DIRECT and HYDRAGEL LDL/HDL CHOL DIRECT 15/30 kits are designed for quantification of the cholesterol carried by the LDL and HDL lipoprotein fractions of human plasma or serum. The analysis is performed in two stages: · electrophoresis on agarose gel to separate the VLDL, LDL and HDL as well as chylomicrons and Lp (a) when present, · visualization of lipoprotein fractions based on a sensitive and cholesterol-specific enzymatic method involving cholesterol esterase and cholesterol oxidase, and a chromogenic system with reduced AEC (amino ethyl carbazole) and peroxidase. The stained electrophoregrams are intended for visual interpretation to confirm identification of the individual fractions and for densitometry to obtain accurate, relative concentrations of cholesterol in the individual lipoprotein fractions If the sample's total cholesterol value is known, cholesterol distribution in g/dL or mol/L concentrations can be calculated. Since the LDL cholesterol and HDL cholesterol assays are of primary interest, laboratories may chose to measure the relative concentration of cholesterol only in the HDL and LDL fractions. The procedure is indicated for the general population for a direct measurement of: - the LDL cholesterol level regardless the triglyceride levels ◆ - . the HDL cholesterol level - the ratio LDL/HDL cholesterol . The HYDRAGEL LDL/HDL CHOL Direct kit is designed for use with a manual electrophoresis apparatus. The kit is intended to run up to 8 samples per gel. The HYDRAGEL 7 LDL/HDL CHOL Direct and HYDRAGEL LDL/HDL CHOL Direct 15/30 kits are designed for use with the semi-automated Hydrasys electrophoresis apparatus. These kits are intended to run up to 7, 15 and 30 samples per gel, respectively.
    Device Description
    Not Found
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    K Number
    K972015
    Device Name
    HYDRAGEL 7,15,30, CHOL-HDL KIT
    Manufacturer
    MORAX
    Date Cleared
    1997-10-27

    (150 days)

    Product Code
    LBT
    Regulation Number
    862.1475
    Why did this record match?
    Product Code :

    LBT

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    HYDRAGEL CHOL-HDL, HYDRAGEL 7 CHOL-HDL, HYDRAGEL 15 CHOL-HDL and HYDRAGEL 30 CHOL-HDL kits are designed for quantification of the cholesterol carried by the HYDRAGEE 50 OFFE Friend or serum. This analysis is performed by electrophoresis on alkaline buffered (pH 9.4) agarose gels. The separated lipoproteins are visualized by a of alkaline banered (p). cholesterol-specific enzymatic reaction. The stained electrophoregrams are to be interpreted visually to confirm identification of the individual fractions and by densitometry to obtain viccurale, relative concentrations of cholesterol in the individual lipoprotein fractions if the somole's total cholesterol value is known, cholesterol distribution in g/l or mol/l concentrations can be calculated. Since the HDL cholesterol assay is of primary interest, laboratories may chose to measure the relative concentration of cholesterol only in the HDL fraction.
    Device Description
    All HYDRAGEL CHOL-HDL kits utilize the same composition of alkaline buffered HYDRAGEL CHOL-HDL agarose gels and the same procedure. It is carried out in two stages: · electrophoresis on agarose gel to separate the VLDL, LDL and HDL as well as chylomicrons and Lp (a) when present, · visualization of lipoprotein fractions based on a sensitive and cholesterol-specific enzymatic method involving cholesterol esterase and cholesterol oxidase, and a chromogenic system with reduced AEC (amino ethyl carbazole) and peroxidase. The HYDRAGEL CHOL-HDL kit is designed for use with a manual electrophoresis apparatus. The kit is intended to run up to 8 samples per gel. The HYDRAGEL 7 CHOL-HDL, HYDRAGEL 15 CHOL-HDL and HYDRAGEL 30 CHOL-HDL kits are designed for use with the semi-automated Hydrasys electrophoresis apparatus. These kits are intended to run up to 7, 15 and 30 samples per gel, respectively.
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