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

    Image Navigator by Immuno Concepts

    K Number: K160265 · Decision Jun 17, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    21
    Registration Numbers
    21
    Same Product Code
    109
    Applicant Total
    4
    Review Days
    136

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    Basic Information

    Device Name
    Image Navigator by Immuno Concepts
    K Number
    K160265
    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
    February 2, 2016
    Decision Date
    June 17, 2016
    Product Code
    DHN
    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
    DHN Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control

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