BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    MIRCOLINE SCREEN FOR COCAINE

    K Number: K911652 · Decision May 15, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    97
    Registration Numbers
    97
    Same Product Code
    144
    Applicant Total
    8
    Review Days
    33

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    Basic Information

    Device Name
    MIRCOLINE SCREEN FOR COCAINE
    K Number
    K911652
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3250
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Applicant
    Drug Screening Systems, Inc.
    Date Received
    April 12, 1991
    Decision Date
    May 15, 1991
    Product Code
    DIO
    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
    DIO Enzyme Immunoassay, Cocaine And Cocaine Metabolites

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    Other Clearances by Drug Screening Systems, Inc.

    K Number Device Name
    K945829 MICROLINE SCREEN FOR BENZODIAZEPINE
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    K933480 MICROLINE SCREEN FOR BARBITURATES
    K921651 MICROLINE SCREEN FOR PHENCYCLIDINE
    K914915 MICROLINE SCREEN FOR CANNABINOID
    K910525 MICROLINE SCREEN FOR METHAMPHETAMINE
    K905491 MICROLINE SCREEN FOR OPIATES