BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    Image Navigator by Immuno Concepts, Immuno Concepts IgG Anti-nDNA Fluorescent Test System

    K Number: K203599 · Decision May 26, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    9
    Registration Numbers
    9
    Same Product Code
    18
    Applicant Total
    1
    Review Days
    898

    Basic Information

    Device Name
    Image Navigator by Immuno Concepts, Immuno Concepts IgG Anti-nDNA Fluorescent Test System
    K Number
    K203599
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5100
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Immuno Concepts N.A., Ltd.
    Date Received
    December 9, 2020
    Decision Date
    May 26, 2023
    Product Code
    KTL
    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
    KTL Anti-Dna Indirect Immunofluorescent Solid Phase

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