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    K Number
    K964409
    Device Name
    HCL - 200 BIOCHEMISTRY ANALYZER
    Manufacturer
    HCL LABORATORY SYSTEMS, INC.
    Date Cleared
    1997-01-22

    (79 days)

    Product Code
    JJFCDQCDTCEKCEOCFJCFRCGSCGXCIGCITCIXCKADCNJFJJQBKNK
    Regulation Number
    862.2170
    Why did this record match?
    Applicant Name (Manufacturer) :

    HCL LABORATORY SYSTEMS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The HCL - 200 is intended for use as an in vitro diagnostic multichannel chemistry analyzer.
    Device Description
    The HCL-200 is an automated discrete random access in vitro diagnostic multichannel chemistry analyzer. It is composed of two modules: - The liquid handling system includes compartments of reagents and samples as well as the pipetting unit. - The reaction module includes the cuvette turntable to which samples and reagents are transferred. A photometer to monitor reaction response is also contained in this unit. Then analyzer is linked to a PC compatible computer which loads software into each of the two modules.
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