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510(k) Data Aggregation

    K Number
    K980757
    Device Name
    ILAB 600 CLINICAL CHEMISTRY SYSTEM
    Manufacturer
    INSTRUMENTATION LABORATORY CO.
    Date Cleared
    1998-04-21

    (53 days)

    Product Code
    CGZ, CEK, CEM, CFJ, CFR, CGA, CGS, CGX, CIC, CIG, CIT, CIX, CJE, CKB, DIH, JFJ, JGJ, JGS, JIX, JJW, JJX, JJY, KHS
    Regulation Number
    862.1170
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    Search-Everything :

    Matched: '862.1210'

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ILab 600 is an automated, random access clinical chemistry analyzer which uses analytical techniques (photometry and potentiometry) for the in vitro quantitation of analytes found in physiological fluids such as serum, plasma, urine and cerebrospinal fluid. The results of the measurements are used as medical diagnostic tools.
    Device Description
    The ILab 600 is an automated, random access clinical chemistry analyzer which uses analytical techniques (photometry and potentiometry) for the in virro quantitation of analytes found in physiological fluids such as serum, plasma, urine and cerebrospinal fluid. The results of the measurements are used as medical diagnostic tools.
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