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

    MICROLINE SCREEN FOR CANNABINOID

    K Number: K914915 · Decision Jan 22, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    103
    Registration Numbers
    103
    Same Product Code
    149
    Applicant Total
    8
    Review Days
    79

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    Basic Information

    Device Name
    MICROLINE SCREEN FOR CANNABINOID
    K Number
    K914915
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3870
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Drug Screening Systems, Inc.
    Date Received
    November 4, 1991
    Decision Date
    January 22, 1992
    Product Code
    LDJ
    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
    LDJ Enzyme Immunoassay, Cannabinoids

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    Other Clearances by Drug Screening Systems, Inc.

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    K921651 MICROLINE SCREEN FOR PHENCYCLIDINE
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