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

    STRATUS LIDOCAINE FLUOROMETRIC ENZYME

    K Number: K843184 · Decision Sep 26, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Same Product Code
    16
    Applicant Total
    149
    Review Days
    44

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    Basic Information

    Device Name
    STRATUS LIDOCAINE FLUOROMETRIC ENZYME
    K Number
    K843184
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3555
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Applicant
    American Dade
    Date Received
    August 13, 1984
    Decision Date
    September 26, 1984
    Product Code
    KLR
    Advisory Committee
    Clinical Toxicology
    Review Advisory Committee
    IM
    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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    K871972 STRATUS IGE FLUOROMETRIC ENZYME IMMUNOASSAY
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