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510(k) Data Aggregation

    K Number
    K962499
    Device Name
    ZYMMUNE AUTOREADER-F FLUORESCENCE MICROPLATE READER
    Manufacturer
    Date Cleared
    1996-09-05

    (71 days)

    Product Code
    Regulation Number
    866.4520
    Why did this record match?
    Product Code :

    JZT

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    In combination with approved microplate tests (such as the Bartels manufactured, Zymmune™ CD4/CD8 Cell monitoring assay kit) the Zymmune™ Auto-Reader F [with software] is intended for use for in vitro quantification and monitoring of T-cell levels.
    Device Description
    The Zymmune™ Auto-Reader F is a microplate reader that measures relative fluorescence signals from samples in a 96-well microplate. The Auto-Reader F is designed to be used with integrated software which collects and reports the measurements made by the microplate reader.
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