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510(k) Data Aggregation

    K Number
    K972409
    Device Name
    AG CHEMISTRY ANALYZER SYSTEM
    Manufacturer
    LANDMARK SCIENTIFIC, INC.
    Date Cleared
    1997-08-28

    (63 days)

    Product Code
    JJG
    Regulation Number
    862.2140
    Why did this record match?
    Applicant Name (Manufacturer) :

    LANDMARK SCIENTIFIC, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The AG" Chemistry Analyzer is indicated for in vitro diagnostic use for the quantitative determination of body fluid constituents using automated spectrophotometric methods.
    Device Description
    The AG" Automated Chemistry Analyzer is the latest in a series of automated blood chemistry analyzers for the clinical chemistry laboratory that have become more and more compact as the miniaturization of the technology of the various components has proceeded. The AG" weighs only 37% as much as the currently marketed device, the ASCA Automated Spin Chemistry Analyzer, and has a "footprint" only about one-third as large. The AG" is controlled with a personal computer with a good color monitor, floppy disk drive, hard drive, and printer. The cuvette rotor has a unique self-contained design. Forty cuvettes make up a single cuvette rotor. Each cuvette is made up of a sample shelf and reagent well. The design allows reactions to be completed in the rotor rather than having to be transferred upon mixing, by centrifugal force, to a separate cuvette or reading chamber. The pump uses a rack and pinion drive with a resolution of 3000 steps. The integrated pipettor/dilutor boasts an accuracy of & 1.0% at full stroke and a precision of & 0.05% CV within-run at full stroke. This provides excellent accuracy and precision over a wide range of volumes and speeds.
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