BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    SMART LEISH, MODEL LGM1-050

    K Number: K081868 · Decision May 25, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Same Product Code
    0
    Applicant Total
    1
    Review Days
    1057

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    Basic Information

    Device Name
    SMART LEISH, MODEL LGM1-050
    K Number
    K081868
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    866.3870
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    U.S. Army Medical Research Institute of Infectious
    Date Received
    July 2, 2008
    Decision Date
    May 25, 2011
    Product Code
    OUZ
    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
    OUZ Nucleic Amplification Assays For The Detection Of Leishmania Nucleic Acids