BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    STATUS DS NICOTINE, ACCUSIGN NICOTINE, BIOSIGN NICOTINE

    K Number: K062565 · Decision Feb 20, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11
    Same Product Code
    6
    Applicant Total
    72
    Review Days
    173

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    Basic Information

    Device Name
    STATUS DS NICOTINE, ACCUSIGN NICOTINE, BIOSIGN NICOTINE
    K Number
    K062565
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.3220
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Princeton BioMeditech Corp.
    Date Received
    August 31, 2006
    Decision Date
    February 20, 2007
    Product Code
    MKU
    Advisory Committee
    Clinical Toxicology
    Review Advisory Committee
    CH
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    MKU Enzyme Immunoassay, Nicotine And Nicotine Metabolites

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