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510(k) Data Aggregation

    K Number
    K973335
    Device Name
    QUATRO SP SAMPLE PROCESSING SYSTEMS (200-499, INCLUSIVE)
    Manufacturer
    ZENYX SCIENTIFIC LTD.
    Date Cleared
    1998-04-30

    (238 days)

    Product Code
    JQW
    Regulation Number
    862.2750
    Why did this record match?
    Applicant Name (Manufacturer) :

    ZENYX SCIENTIFIC LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Quatro SP Series Robotic Sample Processing Systems and their accessories are provided as generic liquid handling systems which must be customized and validated for each user environment, according to in vitro diagnostic test instructions and requirements. The customization can be accomplished by users or can be provided, to customer specifications, by Zenyx authorized representatives.
    Device Description
    Quatro SP Series Sample Processing Systems are bench top, four probe, automated pipettor/dilutors of various sizes (capacities) which are programmed via keypad or personal computer. Optional system components include bar code readers, sample racks for tubes or microplates, workstations, and a washing module. Another option, Concerto software, allows control of the processor from a personal computer and extension of programming capabilities via menu-driven commands. The Quatro SP Series Sample Processing Systems use either stainless steel or teflon coated probe tips. The systems are supplied for generic liquid handing application and must be customized to each user's in vitro test specifications. Training is provided for users who wish to perform their own programming.
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