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

    COZART EIA OPIATES ORAL FLUID KIT

    K Number: K024339 · Decision Apr 7, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Same Product Code
    0
    Applicant Total
    6
    Review Days
    101

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    Basic Information

    Device Name
    COZART EIA OPIATES ORAL FLUID KIT
    K Number
    K024339
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.3240
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Cozart Bioscience , Ltd.
    Date Received
    December 27, 2002
    Decision Date
    April 7, 2003
    Product Code
    DIG
    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
    DIG Cholinesterase Test Paper

    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
    K020920 COZART RAPISCAN ORAL FLUID DRUG TEST - OPIATE/METHADONE
    K011131 METHADONE MICROPLATE EIA URINE APPLICATION