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

    URINE AMPHETAMINES SCREEN FLEX(TM) REAGENT CARTRIDGE

    K Number: K950135 · Decision Mar 30, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    96
    Registration Numbers
    96
    Same Product Code
    224
    Applicant Total
    253
    Review Days
    76

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    Basic Information

    Device Name
    URINE AMPHETAMINES SCREEN FLEX(TM) REAGENT CARTRIDGE
    K Number
    K950135
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3100
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    E.I. Dupont DE Nemours & Co., Inc.
    Date Received
    January 13, 1995
    Decision Date
    March 30, 1995
    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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