BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇬🇧 United Kingdom

    ADVANTAGE MARIJUANA (THC) AND COCAINE HOME DRUG TEST

    K Number: K011962 · Decision Aug 9, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    97
    Registration Numbers
    97
    Same Product Code
    144
    Applicant Total
    10
    Review Days
    48

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    Basic Information

    Device Name
    ADVANTAGE MARIJUANA (THC) AND COCAINE HOME DRUG TEST
    K Number
    K011962
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3250
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Advantage Diagnostics Corp.
    Date Received
    June 22, 2001
    Decision Date
    August 9, 2001
    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 Advantage Diagnostics Corp.

    K Number Device Name
    K023712 ADVANTAGE MULTIPLE DRUGS OF ABUSE TEST
    K013778 PEACE OF MIND HOME DRUG TEST
    K010921 ADVANTAGE MARIJUANA (THC) 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