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

    USDT OPIATE ASSAY COLUMN CATALOG NO. 9000-200

    K Number: K932318 · Decision Jun 15, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    100
    Registration Numbers
    100
    Same Product Code
    214
    Applicant Total
    6
    Review Days
    35

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    Basic Information

    Device Name
    USDT OPIATE ASSAY COLUMN CATALOG NO. 9000-200
    K Number
    K932318
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3650
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    U.S. Drug Testing, Inc.
    Date Received
    May 11, 1993
    Decision Date
    June 15, 1993
    Product Code
    DJG
    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
    DJG Enzyme Immunoassay, Opiates

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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
    K934693 AMPHETAMINE TEST SYSTEM
    K931227 USDT FLOW IMMUNOASSAY SYSTEM, MODEL 9000
    K930985 USDT COCAINE/COCAINE METABOL ASSAY COLUMN,9000-100