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510(k) Data Aggregation

    K Number
    K021688
    Device Name
    NICALERT
    Manufacturer
    NYMOX PHARMACEUTICAL CORPORATION
    Date Cleared
    2002-10-18

    (149 days)

    Product Code
    MRS
    Regulation Number
    862.3220
    Why did this record match?
    Applicant Name (Manufacturer) :

    NYMOX PHARMACEUTICAL CORPORATION

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    NicAlert™ is intended for in vitro diagnostic professional use for the semiquantitative determination of cotinine in urine for the purpose of determining if an individual has been exposed to tobacco products such as cigarettes, pipes, or chewing tobacco within the past 48 hours. The cutoff concentration for the NicAlert™ test is 100 ng/mL. Second hand smoke exposure (environmental tobacco smoke) may cause a positive result in a non-user of tobacco products. The NicAlert™ Positive and Negative Controls are intended for in vitro diagnostic use for the quality control of the NicAlert™ test.
    Device Description
    Not Found
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