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

    SENSITITRE AIM (TM)

    K Number: K110331 · Decision Apr 27, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Same Product Code
    6
    Applicant Total
    7
    Review Days
    83

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    Basic Information

    Device Name
    SENSITITRE AIM (TM)
    K Number
    K110331
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.1640
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Trek Diagnostic Systems, Ltd.
    Date Received
    February 3, 2011
    Decision Date
    April 27, 2011
    Product Code
    LIE
    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
    LIE Reagent/Device, Inoculum Calibration

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