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510(k) Data Aggregation

    K Number
    K980055
    Device Name
    CARESIDE GLOBULIN
    Manufacturer
    EXIGENT DIAGNOSTICS, INC.
    Date Cleared
    1998-01-28

    (22 days)

    Product Code
    JGE, ALB, K91
    Regulation Number
    862.1330
    Why did this record match?
    Product Code :

    JGE

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For in vitro diagnostic use with Exigent Diagnostics CareSide Analyzer to calculate globulin and albumin/globulin ratio from albumin and globulin results generated on the CareSide Analyzer by professionals to aid in the diagnosis and treatment of patients with numerous illnesses including severe liver and renal disease, multiple myeloma, and other disorders of blood globulins.
    Device Description
    The CareSide™ Analyzer uses the Total Protein and Albumin cartridge test results from a single patient sample to determine the globulin concentration and A/G Ratio. Globulin is calculated as the difference between the total protein and albumin concentrations.
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