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

    MICROLINE SCREEN FOR METHAMPHETAMINE

    K Number: K910525 · Decision Apr 5, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Same Product Code
    3
    Applicant Total
    8
    Review Days
    57

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    Basic Information

    Device Name
    MICROLINE SCREEN FOR METHAMPHETAMINE
    K Number
    K910525
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3100
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Applicant
    Drug Screening Systems, Inc.
    Date Received
    February 7, 1991
    Decision Date
    April 5, 1991
    Product Code
    DIT
    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
    DIT Thin Layer Chromatography, Amphetamine

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    K921651 MICROLINE SCREEN FOR PHENCYCLIDINE
    K914915 MICROLINE SCREEN FOR CANNABINOID
    K911652 MIRCOLINE SCREEN FOR COCAINE
    K905491 MICROLINE SCREEN FOR OPIATES