BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇬🇧 United Kingdom

    COZART EIA AMPHETAMINES ORAL FLUID MICROPLATE KIT

    K Number: K033743 · Decision Jun 3, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    96
    Registration Numbers
    96
    Same Product Code
    224
    Applicant Total
    6
    Review Days
    188

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    Basic Information

    Device Name
    COZART EIA AMPHETAMINES ORAL FLUID MICROPLATE KIT
    K Number
    K033743
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3100
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Cozart Bioscience , Ltd.
    Date Received
    November 28, 2003
    Decision Date
    June 3, 2004
    Product Code
    DKZ
    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
    DKZ Enzyme Immunoassay, Amphetamine

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    Other Clearances by Cozart Bioscience , Ltd.

    K Number Device Name
    K021944 COZART EIA COTININE URINE 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