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

    USDT COCAINE/COCAINE METABOL ASSAY COLUMN,9000-100

    K Number: K930985 · Decision Apr 27, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    97
    Registration Numbers
    97
    Same Product Code
    144
    Applicant Total
    6
    Review Days
    61

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    Basic Information

    Device Name
    USDT COCAINE/COCAINE METABOL ASSAY COLUMN,9000-100
    K Number
    K930985
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3250
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    U.S. Drug Testing, Inc.
    Date Received
    February 25, 1993
    Decision Date
    April 27, 1993
    Product Code
    DIO
    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
    DIO Enzyme Immunoassay, Cocaine And Cocaine Metabolites

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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
    K932318 USDT OPIATE ASSAY COLUMN CATALOG NO. 9000-200
    K931227 USDT FLOW IMMUNOASSAY SYSTEM, MODEL 9000