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

    ADVANTAGE MARIJUANA (THC) HOME DRUG TEST

    K Number: K010921 · Decision Jun 25, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    103
    Registration Numbers
    103
    Same Product Code
    149
    Applicant Total
    10
    Review Days
    90

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    Basic Information

    Device Name
    ADVANTAGE MARIJUANA (THC) HOME DRUG TEST
    K Number
    K010921
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3870
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Advantage Diagnostics Corp.
    Date Received
    March 27, 2001
    Decision Date
    June 25, 2001
    Product Code
    LDJ
    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
    LDJ Enzyme Immunoassay, Cannabinoids

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    Other Clearances by Advantage Diagnostics Corp.

    K Number Device Name
    K023712 ADVANTAGE MULTIPLE DRUGS OF ABUSE TEST
    K013778 PEACE OF MIND HOME DRUG TEST
    K011962 ADVANTAGE MARIJUANA (THC) AND COCAINE HOME DRUG TEST
    K003708 ADVANTAGE THC/COCAINE TEST
    K001567 ADVANTAGE THC TEST
    K994227 ADVANTAGE HCG TEST (URINE/SERUM)
    K991883 REDI-TEST OPIATES
    K903416 CANNULA, SURGICAL
    K881369 ADVANCE DIAGNOSTICS DISPOSABLE EYECUP