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

    QMS LIDOCAINE CALIBRATORS, MODEL 0374678

    K Number: K091617 · Decision Jul 17, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    40
    Registration Numbers
    40
    Same Product Code
    122
    Applicant Total
    64
    Review Days
    44

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    Basic Information

    Device Name
    QMS LIDOCAINE CALIBRATORS, MODEL 0374678
    K Number
    K091617
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3200
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Thermo Fisher Scientific
    Date Received
    June 3, 2009
    Decision Date
    July 17, 2009
    Product Code
    DLJ
    Advisory Committee
    Clinical Toxicology
    Review Advisory Committee
    TX
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    DLJ Calibrators, Drug Specific

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