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510(k) Data Aggregation

    K Number
    K991539
    Device Name
    EXCELL 22
    Manufacturer
    Date Cleared
    1999-07-01

    (59 days)

    Product Code
    Regulation Number
    864.5220
    Why did this record match?
    Applicant Name (Manufacturer) :

    MWI, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The EXCELL™ 22, is an in-vitro diagnostic instrument for use in counting blood cells, classifying white blood cells (WBC) and flagging specimens containing abnormal blood cells in clinical laboratories at diverse sites. Per NCCLS H20A section 4(9), flagging is defined as "identifying a sample or blood film for further attention or review".
    Device Description
    The EXCELL 22 is a DATACELL 18MS with an additional optical channel for performing a five-part white cell differential. The five-part optical white cell differential system is substantially equivalent to the Cell-Dyn 3000. Modifications to the DATACELL 18MS present in the new instrument are: - Addition of a laser excited multi dimensional flow cytometer . - . addition of a reagent for the optical flow cell - provision for collecting data from the optical detectors . - replacing of AC motors with DC motors to make the product suitable . for international applications - replacing the internal PC computer and monitor with an external PC to . gain room for the optical detection system - . provision in the slide valve for the additional dilution for the WBC optical measurement - . addition of hydrodynamic focus sample injection system for the WBC - improved dilution logic to speed up the measurement . - improved platelet aperture system called the von Behrens silencer. The operating modes are the same as the DATACELL 18MS.
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