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510(k) Data Aggregation

    K Number
    K014203
    Device Name
    ABX MICROS 60 HEMATOLOGY ANALYZER
    Manufacturer
    ABX DIAGNOSTICS
    Date Cleared
    2002-02-28

    (69 days)

    Product Code
    GKX, GKZ
    Regulation Number
    864.5200
    Why did this record match?
    Product Code :

    GKX

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ABX MICROS 60 Hematology Analyzer is a fully automated (microprocessor controlled) hematology analyzer used for the in vitro diagnostic testing of whole blood specimens or blood cell concentrates. It operates in complete blood count (CBC) mode.
    Device Description
    The ABX MICROS 60 Hematology Analyzer is a bench top clinical laboratory instrument which analyzes in vitro samples of whole blood to provide complete blood count data using principles of cytochemistry, focused flow impedance, and light transmission technology. The system is equipped with automatic calibration; Automated smart cards based for: calibration, QC with 93 multiple range files and memory with 60 erasable results.
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