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

    LIDOCAINE FLUORESCENT IMMUNOASSAY

    K Number: K822347 · Decision Aug 25, 1982
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Same Product Code
    16
    Applicant Total
    39
    Review Days
    19

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    Basic Information

    Device Name
    LIDOCAINE FLUORESCENT IMMUNOASSAY
    K Number
    K822347
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3555
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Applicant
    American Diagnostic Corp.
    Date Received
    August 6, 1982
    Decision Date
    August 25, 1982
    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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