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

    MICROLINE SCREEN FOR OPIATES

    K Number: K905491 · Decision Mar 13, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    100
    Registration Numbers
    100
    Same Product Code
    214
    Applicant Total
    8
    Review Days
    96

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    Basic Information

    Device Name
    MICROLINE SCREEN FOR OPIATES
    K Number
    K905491
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3650
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Applicant
    Drug Screening Systems, Inc.
    Date Received
    December 7, 1990
    Decision Date
    March 13, 1991
    Product Code
    DJG
    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
    DJG Enzyme Immunoassay, Opiates

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    Other Clearances by Drug Screening Systems, Inc.

    K Number Device Name
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    K933480 MICROLINE SCREEN FOR BARBITURATES
    K921651 MICROLINE SCREEN FOR PHENCYCLIDINE
    K914915 MICROLINE SCREEN FOR CANNABINOID
    K911652 MIRCOLINE SCREEN FOR COCAINE
    K910525 MICROLINE SCREEN FOR METHAMPHETAMINE