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

    EUROIMMUN IFA: Crithidia luciliae (anti-dsDNA) EUROPattern

    K Number: K172244 · Decision Apr 20, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    8
    Registration Numbers
    8
    Same Product Code
    18
    Applicant Total
    19
    Review Days
    268

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    Basic Information

    Device Name
    EUROIMMUN IFA: Crithidia luciliae (anti-dsDNA) EUROPattern
    K Number
    K172244
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5100
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Euroimmun Us, Inc.
    Date Received
    July 26, 2017
    Decision Date
    April 20, 2018
    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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    Other Clearances by Euroimmun Us, Inc.

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