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510(k) Data Aggregation

    K Number
    K961623
    Device Name
    FACSCOMP SOFTWARE & CALIBRITE 3 COLOR BEADS KIT/CALIBRITE PERCP BEADS
    Manufacturer
    BECTON DICKINSON MONOCLONAL CENTER
    Date Cleared
    1996-06-07

    (42 days)

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

    BECTON DICKINSON MONOCLONAL CENTER

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For flow cytometer set up and monitoring of instrument performance. The procedure employs a Becton Dickinson flow cytometer and recommended computer hardware and software.
    Device Description
    Becton Dickinson CaliBRITE 3 Color and FACSComp are intended for use on the Becton Dickinson flow cytometers FACScan™ or FACSort or FACSCalibur™. FACSComp Software and CaliBRITE 3 Color Beads are used to optimally adjust instrument settings, to monitor the sensitivity, and to set the compensation of flow cytometers for spectral overlap of fluorescent dyes. FACSComp Software and CaliBRITE 3 Color Beads are used to set up and verify the separation of system noise from forward and side scatter and to set fluorescence compensation on flow cytometers with three FL channels. FACSComp Software and CaliBRITE 3 Color Beads are used for setting the photomultiplier tube (PMT) voltages, setting the fluorescence compensation, and checking instrument sensitivity on thow cytometers. This product is recommended for instrument set up prior to running Becton Dickinson software applications for flow cytometers. CaliBRITE 3 Color will be provided as a Kit, comprising unstained, FITC, PE and PerCP beads. CaliBRITE PerCP beads will also be provided as a separate product, to be used with CaliBRITE Kits having unstained FITC and PE beads only.
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