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

    EUROIMMUN ANA IFA: HEP-20-10

    K Number: K070763 · Decision May 22, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    21
    Registration Numbers
    21
    Same Product Code
    109
    Applicant Total
    6
    Review Days
    63

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    Basic Information

    Device Name
    EUROIMMUN ANA IFA: HEP-20-10
    K Number
    K070763
    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, LLC
    Date Received
    March 20, 2007
    Decision Date
    May 22, 2007
    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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