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

    WEST NILE VIRUS IGM CAPTURE ELISA, MODEL EL0300M

    K Number: K031952 · Decision Oct 22, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    9
    Registration Numbers
    9
    Same Product Code
    9
    Applicant Total
    5
    Review Days
    119

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    Basic Information

    Device Name
    WEST NILE VIRUS IGM CAPTURE ELISA, MODEL EL0300M
    K Number
    K031952
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.3940
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Focus Technologies, Inc.
    Date Received
    June 25, 2003
    Decision Date
    October 22, 2003
    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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    Other Clearances by Focus Technologies, Inc.

    K Number Device Name
    K040854 WEST NILE VIRUS IGM CAPTURE ELISA
    K031953 WEST NILE VIRUS ELISA IGG, MODEL EL0300G
    K021486 HERPESELECT 2 ELISA IGG, MODEL ELO920G
    K021429 HERPESELECT 1 ELISA IGG, MODEL EL0910G