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510(k) Data Aggregation

    K Number
    K013249
    Device Name
    TINA-QUANT APOLIPOPROTEIN VER.2
    Manufacturer
    ROCHE DIAGNOSTICS CORP.
    Date Cleared
    2001-11-16

    (49 days)

    Product Code
    DER
    Regulation Number
    866.5580
    Why did this record match?
    Product Code :

    DER

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Immunoturbidmetric assay for the in vitro quantitative determination of apolipoprotein A-1 in human serum and plasma on automated clinical chemistry analyzers. A lipoprotein test system is a device intended to measure lipoprotein in serum and plasma. Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders and atherosclerosis.
    Device Description
    A device for the measurement of human apolipoprotein A-1 in serum or plasma. Anti-apolipoprotein A-1 antibodies react with the antigen in the sample to form antigen/antibody complexes which, following agglutination, are measured turbidimetrically.
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    K Number
    K000921
    Device Name
    BAYER ADVIA IMS SYSTEM; 200 + 3
    Manufacturer
    BAYER CORP.
    Date Cleared
    2000-05-18

    (57 days)

    Product Code
    DER, CFR, DFC
    Regulation Number
    866.5580
    Why did this record match?
    Product Code :

    DER

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K993354
    Device Name
    K-ASSAY APO B
    Manufacturer
    KAMIYA BIOMEDICAL CO.
    Date Cleared
    1999-10-28

    (23 days)

    Product Code
    DER
    Regulation Number
    866.5580
    Why did this record match?
    Product Code :

    DER

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The K-ASSAY Apo B Assay is intended to be used for the quantitative determination of Apo B in human serum by immunoturbidimetric assay. Apolipoprotein measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis and related diseases. FOR IN VITRO DIAGNOSTIC USE.
    Device Description
    Not Found
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    K Number
    K993345
    Device Name
    K-ASSAY APO AI
    Manufacturer
    KAMIYA BIOMEDICAL CO.
    Date Cleared
    1999-10-25

    (20 days)

    Product Code
    DER
    Regulation Number
    866.5580
    Why did this record match?
    Product Code :

    DER

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The K-ASSAY Apo Al Assay is intended to be used for the quantitative determination of Apo Al in human serum by immunoturbidimetric assay. Apolipoprotein measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases. FOR IN VITRO DIAGNOSTIC USE.
    Device Description
    Not Found
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    K Number
    K990594
    Device Name
    INTEGRA REAGENT CASSETTE FOR APOLIPOPROTEIN A-1
    Manufacturer
    ROCHE DIAGNOSTICS CORP.
    Date Cleared
    1999-04-14

    (49 days)

    Product Code
    DER
    Regulation Number
    866.5580
    Why did this record match?
    Product Code :

    DER

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For in vitro quantitative determination Apolipoprotein A-1 in serum and plasma. Apolipoprotein A-1 measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases.
    Device Description
    The device is an immunoturbidimetric test for the quantitative determination of Apolipoprotein A-1 in serum and plasma for use on the INTEGRA family of analyzers.
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    K Number
    K983289
    Device Name
    APOLIPOPROTEIN A1
    Manufacturer
    ABBOTT LABORATORIES
    Date Cleared
    1999-01-29

    (133 days)

    Product Code
    DER
    Regulation Number
    866.5580
    Why did this record match?
    Product Code :

    DER

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Apolipoprotein A1 assay is used for the quantitation of apolipoprotein A1 in human serum or plasma. Measurement of A lipoproteins, the major proteins found in HDL (high density lipoprotein), is used in the diagnosis and treatment of premature coronary artery disease, hyper-a-lipoproteinemia, and hypo-α-lipoproteinemia.
    Device Description
    Apolipoprotein A1 is an in vitro diagnostic assay for the quantitative determination of apolipoprotein A1 in human serum or plasma. Antibodies to apolipoprotein A1 combine with apolipoprotein A1 in the sample to form insoluble immune complexes. The immune complexes cause an increase in light scattering (turbidity). The resulting increase in sample turbidity, measured at 804 nm, is directly proportional to the concentration of apolipoprotein A1 in the sample.
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    K Number
    K964292
    Device Name
    N-ASSAY TIA APO A1 TEST KIT
    Manufacturer
    CRESTAT DIAGNOSTICS, INC.
    Date Cleared
    1997-08-01

    (276 days)

    Product Code
    DER
    Regulation Number
    866.5580
    Why did this record match?
    Product Code :

    DER

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The N-Assay TIA Apoprotein A-l Test Kit is intended to be used for the quantitative determination of human apoprotein a successor and in numan serum by immunoturòid assay. The measurement in numan serum by immunoturòid assay. The measurement in numan serum by immondtoldimetric assay. The meadershow. of apoprotein A-l is useful in the diagnosis of atherosclerosis.
    Device Description
    Not Found
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    K Number
    K964294
    Device Name
    N-ASSAY TIA APO A1/B MULTI CALIBRATOR
    Manufacturer
    CRESTAT DIAGNOSTICS, INC.
    Date Cleared
    1997-08-01

    (276 days)

    Product Code
    DER
    Regulation Number
    866.5580
    Why did this record match?
    Product Code :

    DER

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The N-Assay TIA Apoprotein A/B Calibrator is intended to be used for the calibration of the Crestat Diagnostics N-Assay TIA Apoprotein A-1 and Apoprotein B Test Kits. which are immuno turbidimetric assays for the measurement of Apo Apoprotein A-1 and Apoprotein B in human serum.
    Device Description
    Not Found
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    K Number
    K964296
    Device Name
    N-ASSAY TIA APO B TEST KIT
    Manufacturer
    CRESTAT DIAGNOSTICS, INC.
    Date Cleared
    1997-08-01

    (276 days)

    Product Code
    DER
    Regulation Number
    866.5580
    Why did this record match?
    Product Code :

    DER

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The N-Assay TIA APO B Test Kit is intended to be used for the quantitative determination of human apolipoprotein B in human serum by immunoturbidimetric assay. The measurement of Apolipoproteinbis useful in the diagnosis of atherosclerosis.
    Device Description
    Not Found
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