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

    EUROIMMUN ANTI-SLA/LP ELISA(LGG)

    K Number: K112221 · Decision Sep 11, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Same Product Code
    2
    Applicant Total
    12
    Review Days
    406

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    Basic Information

    Device Name
    EUROIMMUN ANTI-SLA/LP ELISA(LGG)
    K Number
    K112221
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5660
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Euroimmun US
    Date Received
    August 2, 2011
    Decision Date
    September 11, 2012
    Product Code
    NIY
    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
    NIY Autoantibodies, Anti-Soluble Liver Antigen (Sla), Autoimmune Hepatitis

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