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

    EUROIMMUN EUROLINE ENA PROFILE 9AG (IGG)

    K Number: K140224 · Decision Dec 9, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    13
    Registration Numbers
    13
    Same Product Code
    22
    Applicant Total
    12
    Review Days
    314

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    Basic Information

    Device Name
    EUROIMMUN EUROLINE ENA PROFILE 9AG (IGG)
    K Number
    K140224
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5100
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Euroimmun US
    Date Received
    January 29, 2014
    Decision Date
    December 9, 2014
    Product Code
    LKO
    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
    LKO Anti-Rnp Antibody, Antigen And Control

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    Other Clearances by Euroimmun US

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    K131791 IFA 40: HEP-20-10
    K123660 25-OH VITAMIN D ELISA
    K131185 ANA SCREEN ELISA (IGG)
    K123261 EUROIMMUN ANTI-NRNP/SM ELISA (IGG)
    K113439 EUROIMMUN EUROLINE PROFILE AUTOIMMUNE LIVER DISEASE 8AG (IGG)
    K112996 EUROIMMUN ANTI-ENA POOL ELISA (IGG)
    K112221 EUROIMMUN ANTI-SLA/LP ELISA(LGG)
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