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

    RAPIDSENSE DRUGS OF ABUSE PHENCYCLIDINE (PCP) 25 DEVICE WITH MODELS 900-0054

    K Number: K080431 · Decision Jan 8, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    96
    Registration Numbers
    96
    Same Product Code
    87
    Applicant Total
    4
    Review Days
    324

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    Basic Information

    Device Name
    RAPIDSENSE DRUGS OF ABUSE PHENCYCLIDINE (PCP) 25 DEVICE WITH MODELS 900-0054
    K Number
    K080431
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Quantrx Biomedical Corporation
    Date Received
    February 19, 2008
    Decision Date
    January 8, 2009
    Product Code
    LCM
    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
    LCM Enzyme Immunoassay, Phencyclidine

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    Other Clearances by Quantrx Biomedical Corporation

    K Number Device Name
    K080436 RAPIDSENSE DRUGS OF ABUSE COCAINE (COC) 300 DEVICE, MODEL 900-0052
    K080455 RAPIDSENSE DRUGS OF ABUSE METHAMPHETAMINE (MET) 1000 DEVICE, MODEL 900-0050
    K070484 QUANTRX FEMALE FERTILITY TEST