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

    MICROLINE SCREEN FOR BARBITURATES

    K Number: K933480 · Decision Oct 29, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    88
    Registration Numbers
    88
    Same Product Code
    99
    Applicant Total
    8
    Review Days
    106

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    Basic Information

    Device Name
    MICROLINE SCREEN FOR BARBITURATES
    K Number
    K933480
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3150
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Drug Screening Systems, Inc.
    Date Received
    July 15, 1993
    Decision Date
    October 29, 1993
    Product Code
    DIS
    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
    DIS Enzyme Immunoassay, Barbiturate

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    Other Clearances by Drug Screening Systems, Inc.

    K Number Device Name
    K945829 MICROLINE SCREEN FOR BENZODIAZEPINE
    K935052 MICROLINE SCREEN FOR AMPHETAMINE
    K921651 MICROLINE SCREEN FOR PHENCYCLIDINE
    K914915 MICROLINE SCREEN FOR CANNABINOID
    K911652 MIRCOLINE SCREEN FOR COCAINE
    K910525 MICROLINE SCREEN FOR METHAMPHETAMINE
    K905491 MICROLINE SCREEN FOR OPIATES