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

    METHADONE MICROPLATE EIA URINE APPLICATION

    K Number: K011131 · Decision Jul 31, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    83
    Registration Numbers
    83
    Same Product Code
    62
    Applicant Total
    6
    Review Days
    109

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    Basic Information

    Device Name
    METHADONE MICROPLATE EIA URINE APPLICATION
    K Number
    K011131
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3620
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Cozart Bioscience , Ltd.
    Date Received
    April 13, 2001
    Decision Date
    July 31, 2001
    Product Code
    DJR
    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
    DJR Enzyme Immunoassay, Methadone

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    Other Clearances by Cozart Bioscience , Ltd.

    K Number Device Name
    K033743 COZART EIA AMPHETAMINES ORAL FLUID MICROPLATE KIT
    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