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

    WEST NILE DETECT IGM ELISA

    K Number: K041817 · Decision Nov 19, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    9
    Registration Numbers
    9
    Same Product Code
    9
    Applicant Total
    6
    Review Days
    136

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    Basic Information

    Device Name
    WEST NILE DETECT IGM ELISA
    K Number
    K041817
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.3940
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Inbios Intl., Inc.
    Date Received
    July 6, 2004
    Decision Date
    November 19, 2004
    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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