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510(k) Data Aggregation

    K Number
    K231151
    Device Name
    Kenota 1 Total IgE; Kenota 1 (instrument)
    Manufacturer
    Kenota Inc.
    Date Cleared
    2024-05-31

    (403 days)

    Product Code
    DGC
    Regulation Number
    866.5510
    Why did this record match?
    Applicant Name (Manufacturer) :

    Kenota Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Kenota 1 Total IgE is an in vitro test system intended for semi-quantitative measurement of total IgE in human capillary whole blood on the Kenota 1 instrument. It is intended for in vitro diagnostic use as an aid in the clinical diagnosis of IgE-mediated allergic disorders in conjunction with other clinical findings, and is to be used in allergist/immunologist offices.
    Device Description
    The Kenota 1 Total IgE test system consists of Kenota 1 Total IgE Cartridge (reagent) and other test components, including Kenota 1 Total IgE External Controls (EC), Kenota 1 (instrument), Kenota 1 Sample Collection Kit (SCK), and Kenota 1 Developing Solution.
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