BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇬🇧 United Kingdom

    COZART EIA COTININE URINE KIT

    K Number: K021944 · Decision May 14, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11
    Same Product Code
    6
    Applicant Total
    6
    Review Days
    335

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    Basic Information

    Device Name
    COZART EIA COTININE URINE KIT
    K Number
    K021944
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.3220
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Cozart Bioscience , Ltd.
    Date Received
    June 13, 2002
    Decision Date
    May 14, 2003
    Product Code
    MKU
    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
    MKU Enzyme Immunoassay, Nicotine And Nicotine Metabolites

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    Other Clearances by Cozart Bioscience , Ltd.

    K Number Device Name
    K033743 COZART EIA AMPHETAMINES ORAL FLUID MICROPLATE KIT
    K030234 COZART EIA COCAINE ORAL FLIUD KIT
    K024339 COZART EIA OPIATES ORAL FLUID KIT
    K020920 COZART RAPISCAN ORAL FLUID DRUG TEST - OPIATE/METHADONE
    K011131 METHADONE MICROPLATE EIA URINE APPLICATION