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

    MICROLINE SCREEN FOR AMPHETAMINE

    K Number: K935052 · Decision Sep 16, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    96
    Registration Numbers
    96
    Same Product Code
    224
    Applicant Total
    8
    Review Days
    331

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    Basic Information

    Device Name
    MICROLINE SCREEN FOR AMPHETAMINE
    K Number
    K935052
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3100
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Drug Screening Systems, Inc.
    Date Received
    October 20, 1993
    Decision Date
    September 16, 1994
    Product Code
    DKZ
    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
    DKZ Enzyme Immunoassay, Amphetamine

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    Other Clearances by Drug Screening Systems, Inc.

    K Number Device Name
    K945829 MICROLINE SCREEN FOR BENZODIAZEPINE
    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
    K905491 MICROLINE SCREEN FOR OPIATES