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    K Number
    K040750
    Device Name
    BIO-CHEM ANALYZER, MODEL 100
    Manufacturer
    CLINICAL ANALYSIS CORPORATION, INC.
    Date Cleared
    2004-10-28

    (219 days)

    Product Code
    CEM
    Regulation Number
    862.1600
    Why did this record match?
    Applicant Name (Manufacturer) :

    CLINICAL ANALYSIS CORPORATION, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The CAC Bio-Chem AnalyzerTM is a microprocessor-controlled instrument for the quantitative determination of specific analytes in whole blood and plasma. The instrument deploys single-use, single analyte disposable test books of the following test analyte: potassium. Potassium measurements obtained by this device are used to monitor electrolyte balance in the diagnosis and treatment of conditions characterized by low or high blood potassium levels. The CAC Bio-Chem Analyzer™ is a point-of-care device intended for hospital-use settings.
    Device Description
    The CAC Bio-Chem AnalyzerTM is a microprocessor-controlled instrument for the quantitative determination of specific analytes in whole blood and plasma. The instrument deploys single-use, single analyte disposable test books of the following test analyte: potassium.
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