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

    URINE THC CANNABINOIDS DIRECT RIA KIT

    K Number: K833911 · Decision Jan 24, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    15
    Applicant Total
    50
    Review Days
    71

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    Basic Information

    Device Name
    URINE THC CANNABINOIDS DIRECT RIA KIT
    K Number
    K833911
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3870
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Applicant
    Immunalysis Corporation
    Date Received
    November 14, 1983
    Decision Date
    January 24, 1984
    Product Code
    LAT
    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
    LAT Radioimmunoassay, Cannabinoid(S)

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