BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇦 Canada

    SPECTRAL WEST NILE VIRUS IGM STATUS TEST

    K Number: K052519 · Decision Nov 30, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    9
    Registration Numbers
    9
    Same Product Code
    9
    Applicant Total
    12
    Review Days
    442

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    Basic Information

    Device Name
    SPECTRAL WEST NILE VIRUS IGM STATUS TEST
    K Number
    K052519
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.3940
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Spectral Diagnostics, Inc.
    Date Received
    September 14, 2005
    Decision Date
    November 30, 2006
    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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