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

    PEACE OF MIND HOME DRUG TEST

    K Number: K013778 · Decision Feb 7, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Same Product Code
    17
    Applicant Total
    10
    Review Days
    86

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    Basic Information

    Device Name
    PEACE OF MIND HOME DRUG TEST
    K Number
    K013778
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Advantage Diagnostics Corp.
    Date Received
    November 13, 2001
    Decision Date
    February 7, 2002
    Product Code
    MVO
    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
    MVO Kit, Test, Multiple, Drugs Of Abuse, Over The Counter

    Similar 510(k) Clearances

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    ACCU-STAT HOME DRUG TESTS FOR MARIJUANA (THC) AND FOR MARIJUANA & COCAINE (THC, COC)

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    LIFESIGN MET, STATUS STIK MET, ACCUSIGN STIK MET, ACCUSTIK MET, ACCUSIGN MET, STATUS DS MET

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    FDA Unclassified ·Unknown

    AT HOME DRUG TEST, MODEL 9069

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    AT HOME DRUG TEST, MODEL 9064

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    AT HOME DRUG TEST, MODEL 9074

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    Other Clearances by Advantage Diagnostics Corp.

    K Number Device Name
    K023712 ADVANTAGE MULTIPLE DRUGS OF ABUSE TEST
    K011962 ADVANTAGE MARIJUANA (THC) AND COCAINE 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