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510(k) Data Aggregation

    K Number
    K962294
    Device Name
    IMMAGE IMMUNOCHEMISTRY SYSTEM
    Date Cleared
    1996-08-21

    (68 days)

    Product Code
    Regulation Number
    862.2700
    Why did this record match?
    Product Code :

    JQX

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The IMMAGE Immunochemistry System is a fully automated, computer controlled, bench-top chemistry analyzer intended for the in vitro quantitative measurement of therapeutic drugs and specific components of clinical use in biological fluids.
    Device Description
    The IMMAGE Immunochemistry System is a fully automated, computer controlled, bench-top chemistry analyzer intended for the in vitro quantitative determination of specific components and therapeutic drugs of clinical interest in biological fluids such as serum, plasma, urine, and cerebral spinal fluid. The analyzer operates in conjunction with reagents, calibrators, and controls designed for use with the system. The instrument features barcode identification of samples and reagents. It automatically dilutes samples and delivers them to the reaction cuvette along with reagents and reaction constituents. The system analyzes up to 72 samples per run with up to 24 analytes per sample. Major hardware components include a reagent compartment, and reagent cranes, reaction module, sample carousel and crane, sample hydropheumatics, electronics, and power supplies.
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