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510(k) Data Aggregation

    K Number
    K061879
    Device Name
    SDI CA480 CLINICAL CHEMISTRY SYSTEM; SATURNO 300 CLINICAL CHEMISTRY SYSTEM
    Date Cleared
    2006-12-15

    (165 days)

    Product Code
    Regulation Number
    862.1345
    Why did this record match?
    Applicant Name (Manufacturer) :

    HEMODIAGNOSTICA, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The SDI CA480 Clinical Chemistry System includes a discrete, random access, microprocessor controlled clinical chemistry analyzer and dedicated reagents intended for in vitro diagnostic quantitative measurement of Glucose, Blood Urea Nitrogen (BUN), Sodium, Potassium and Chloride in serum. Other various chemistry assays are adaptable to the analyzer. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma. BUN measurements are use in the diagnosis and treatment of certain renal and metabolic diseases. Sodium measurements are used in the diagnosis and treatment of diseases involving electrolyte imbalance. Potassium measurements monitor electrolyte balance and are used in the diagnosis and treatment of disease conditions characterized by low or high blood potassium levels. Chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders.
    Device Description
    The SDI CA480 is a discrete, random access, microprocessor controlled photometric analyzer with the capability to perform 300 clinical chemistry tests per hour with an additional 180 ISE tests per hour for a total throughput of 480 tests per hour. The analyzer is comprised of three main components: sample system, reagent system, and measurement system. The analyzer utilizes hardware controlled robotics for pipetting, transport, dispensing and stirring of reagents and samples, The measurement system features a halogen lamp, filter wheel and photodiode for optical detection and reusable quartz reaction cuvettes which are automatically washed and dried between samples. The integrated ISE module allows for Na/K/Cl electrolyte tests.
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