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

    USDT PHENCYCLIDINE (PCP) ASSAY COLUMN CAT. NO. 9000-400

    K Number: K935629 · Decision Apr 12, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    96
    Registration Numbers
    96
    Same Product Code
    87
    Applicant Total
    6
    Review Days
    140

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    Basic Information

    Device Name
    USDT PHENCYCLIDINE (PCP) ASSAY COLUMN CAT. NO. 9000-400
    K Number
    K935629
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    U.S. Drug Testing, Inc.
    Date Received
    November 23, 1993
    Decision Date
    April 12, 1994
    Product Code
    LCM
    Advisory Committee
    Unknown
    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
    LCM Enzyme Immunoassay, Phencyclidine

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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
    K934693 AMPHETAMINE TEST SYSTEM
    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