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

    SENSITITRE OPTIREAD

    K Number: K110583 · Decision Sep 22, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    10
    Registration Numbers
    10
    Same Product Code
    44
    Applicant Total
    7
    Review Days
    205

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    Basic Information

    Device Name
    SENSITITRE OPTIREAD
    K Number
    K110583
    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
    March 1, 2011
    Decision Date
    September 22, 2011
    Product Code
    LRG
    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
    LRG Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems

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