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

    LIDOCAINE CALIBRATOR KIT

    K Number: K780731 · Decision Jan 17, 1979
    View on FDA
    Classifications
    1
    FEI Numbers
    40
    Registration Numbers
    40
    Same Product Code
    122
    Applicant Total
    39
    Review Days
    260

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    Basic Information

    Device Name
    LIDOCAINE CALIBRATOR KIT
    K Number
    K780731
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3200
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Applicant
    Vitek Systems, Inc.
    Date Received
    May 2, 1978
    Decision Date
    January 17, 1979
    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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