BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇦 Canada

    Kenota 1 Total IgE; Kenota 1 (instrument)

    K Number: K231151 · Decision May 31, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    30
    Registration Numbers
    30
    Same Product Code
    113
    Applicant Total
    1
    Review Days
    403

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    Basic Information

    Device Name
    Kenota 1 Total IgE; Kenota 1 (instrument)
    K Number
    K231151
    Device Class
    FDA class 2
    Clearance Type
    Dual Track
    Regulation Number
    866.5510
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Kenota, Inc.
    Date Received
    April 24, 2023
    Decision Date
    May 31, 2024
    Product Code
    DGC
    Advisory Committee
    Immunology
    Review Advisory Committee
    IM
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    DGC Ige, Antigen, Antiserum, Control

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