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

    RAPID FORSURE ONE STEP MULTIPLE DRUG (UP TO 6) SCREEN TEST DEVICE FOR AMPHETAMINE, METHAMPHETAMINE, BENZOYLECGONINE, THC

    K Number: K052520 · Decision Apr 24, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    106
    Registration Numbers
    106
    Same Product Code
    209
    Applicant Total
    11
    Review Days
    222

    Basic Information

    Device Name
    RAPID FORSURE ONE STEP MULTIPLE DRUG (UP TO 6) SCREEN TEST DEVICE FOR AMPHETAMINE, METHAMPHETAMINE, BENZOYLECGONINE, THC
    K Number
    K052520
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3650
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Tianjin New Bay Bioresearch Co., Ltd.
    Date Received
    September 14, 2005
    Decision Date
    April 24, 2006
    Product Code
    DJG
    Advisory Committee
    Clinical Toxicology
    Review Advisory Committee
    CH
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    DJG Enzyme Immunoassay, Opiates

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