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

    AMPHETAMINE TEST SYSTEM

    K Number: K934693 · Decision Nov 22, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    96
    Registration Numbers
    96
    Same Product Code
    224
    Applicant Total
    6
    Review Days
    53

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    Basic Information

    Device Name
    AMPHETAMINE TEST SYSTEM
    K Number
    K934693
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3100
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    U.S. Drug Testing, Inc.
    Date Received
    September 30, 1993
    Decision Date
    November 22, 1993
    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 U.S. Drug Testing, Inc.

    K Number Device Name
    K940912 USDT CANNABINOID (THC) ASSAY COLUMN CATALOG NO. 9000-500
    K935629 USDT PHENCYCLIDINE (PCP) ASSAY COLUMN CAT. NO. 9000-400
    K932318 USDT OPIATE ASSAY COLUMN CATALOG NO. 9000-200
    K931227 USDT FLOW IMMUNOASSAY SYSTEM, MODEL 9000
    K930985 USDT COCAINE/COCAINE METABOL ASSAY COLUMN,9000-100