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

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

    K Number: K040327 · Decision Apr 19, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Same Product Code
    17
    Applicant Total
    3
    Review Days
    69

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    Basic Information

    Device Name
    ACCU-STAT HOME DRUG TESTS FOR MARIJUANA (THC) AND FOR MARIJUANA & COCAINE (THC, COC)
    K Number
    K040327
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Accu-Stat Diagnostics, Inc.
    Date Received
    February 10, 2004
    Decision Date
    April 19, 2004
    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

    Other 510(k) clearances with the same product code (MVO), ordered by most recent decision date.

    AT HOME DRUG CUP, MODEL 9150X

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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

    PEACE OF MIND HOME DRUG TEST

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    FDA Unclassified ·Unknown

    AT HOME DRUG TEST, MODEL 9069

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    FDA Unclassified ·Unknown

    AT HOME DRUG TEST, MODEL 9064

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    FDA Unclassified ·Unknown

    AT HOME DRUG TEST, MODEL 9074

    FDA 510(k)
    FDA Unclassified ·Unknown
    View all

    Other Clearances by Accu-Stat Diagnostics, Inc.

    K Number Device Name
    K041221 ACCU-STAT HOME DRUG TEST CUP FOR MAIJUANNA (THC), COCAINE (COC), AMPHETAMINE (AMP), METHAMPHETAMINE (MAMP), ECSTASY
    K040629 ACCU-STAT HOME DRUG TEST FOR MARIJUANA, COCAINE, AMPHETAMINE, METHAMPHETAMINE, OPIATES, AND PHENCYCLIDINE