BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    USDT FLOW IMMUNOASSAY SYSTEM, MODEL 9000

    K Number: K931227 · Decision May 6, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4
    Same Product Code
    14
    Applicant Total
    6
    Review Days
    57

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    Basic Information

    Device Name
    USDT FLOW IMMUNOASSAY SYSTEM, MODEL 9000
    K Number
    K931227
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.2260
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    U.S. Drug Testing, Inc.
    Date Received
    March 10, 1993
    Decision Date
    May 6, 1993
    Product Code
    KZR
    Advisory Committee
    Clinical Chemistry
    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
    KZR Chromatography (Liquid, Gel), Clinical Use

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    Other Clearances by U.S. Drug Testing, Inc.

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    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
    K930985 USDT COCAINE/COCAINE METABOL ASSAY COLUMN,9000-100