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

    QMS LIDOCAINE

    K Number: K090282 · Decision May 29, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Same Product Code
    16
    Applicant Total
    1
    Review Days
    113

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    Basic Information

    Device Name
    QMS LIDOCAINE
    K Number
    K090282
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3555
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Thermo Fisher Scientific, Inc.
    Date Received
    February 5, 2009
    Decision Date
    May 29, 2009
    Product Code
    KLR
    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
    KLR Enzyme Immunoassay, Lidocaine

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