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510(k) Data Aggregation

    K Number
    K990039
    Device Name
    GAMBRO DQM 200
    Manufacturer
    GAMBRO HEALTHCARE
    Date Cleared
    2000-01-27

    (386 days)

    Product Code
    LFP
    Regulation Number
    862.1770
    Why did this record match?
    Product Code :

    LFP

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Gambro Dialysis Quality Monitor DQM 200 is to act as a clinical tool aiding the physician to establish a dialysis dose of treatment of the patient. The DQM 200 performs a continuous measurement of the spent dialysate flow from a dialysis machine. From this measured data together with patient and treatment data provided by the operator, the DQM 200 derives clinical parameters helpful to the physician in evaluating the dialysis dose.
    Device Description
    The Gambro DOM 200 measures the urea concentration in the dialysis solution leaving the waste outlet of a dialysis machine. Measurements obtained by this device are used in the treatment of certain renal diseases for patients on hemodialysis. The purpose of the Gambro DQM 200is to act as a clinical tool aiding the physician to evaluate the dialysis dose of a treatment. The DQM 200 performs a continuous urea measurement of the spent dialysate flow from a Cobe C3 machine, A Gambro AK 10 Machine, a Gambro AK 100/200 or a Gambro AK 100/200 ULTRA machine. From this measured data together with patient and treatment data provided by the operator of the DOM 200 derives clinical parameters to help define the dialysis dose. The urea measurement is achieved by catalyzing urea with the urease enzyme, with carbon dioxide gas present into ammonium ions and bicarbonate ions. The produced ions cause an increase in the electrical conductivity in proportion to the urea concentration.
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    K Number
    K992847
    Device Name
    HICHEM BUN REAGENT
    Manufacturer
    ELAN HOLDINGS, INC.
    Date Cleared
    1999-10-14

    (51 days)

    Product Code
    LFP
    Regulation Number
    862.1770
    Why did this record match?
    Product Code :

    LFP

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    HiChem® BUN Reagent is intended for the quantitative determination of urea nitrogen in serum, plasma and urine on the Beckman® SYNCHRON CX® and CX® DELTA Systems. Urea nitrogen results are used in the treatment of numerous renal and metabolic diseases. This reagent is intended for professional use only.
    Device Description
    HiChem® BUN Reagent is intended for the quantitative determination of urea nitrogen in serum, plasma and urine on the Beckman® SYNCHRON CX® and CX® DELTA Systems.
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    K Number
    K963537
    Device Name
    SIGMA DIAGNOSTICS BUN REAGENT
    Manufacturer
    SIGMA DIAGNOSTICS, INC.
    Date Cleared
    1996-10-24

    (50 days)

    Product Code
    LFP
    Regulation Number
    862.1770
    Why did this record match?
    Product Code :

    LFP

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The level of blood urea nitrogen (BUN) is regulated by the metabolism of proteins and by the renal excretion of urea. BUN determination, therefore, has become the most widely used screening procedure for evaluating kidney function. Increased BUN levels occur in cases of impaired kidney function such as chronic nephritis, acute glomerulonephritis, polycystic disease of the kidney, nephrosclerosis and tubular necrosis. BUN levels are also elevated due to urinary tract obstruction and during the terminal stage of liver disease. Decrease in BUN levels often accompany primary hepatic insufficiency and acute hepatitis.
    Device Description
    The Sigma Diagnostics BUN Reagent is formulated to use this methodology on the SYNCHRON CX 3 System.
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