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

    EUROIMMUN Anti-West Nile Virus ELISA (IgM)

    K Number: K153308 · Decision Aug 12, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    9
    Registration Numbers
    9
    Same Product Code
    9
    Applicant Total
    19
    Review Days
    269

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    Basic Information

    Device Name
    EUROIMMUN Anti-West Nile Virus ELISA (IgM)
    K Number
    K153308
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.3940
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Euroimmun Us, Inc.
    Date Received
    November 17, 2015
    Decision Date
    August 12, 2016
    Product Code
    NOP
    Advisory Committee
    Microbiology
    Review Advisory Committee
    MI
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    NOP Elisa, Antibody, West Nile Virus

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