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

    FORSURE ONE STEP BUPRENORPHINE CUP TEST DEVICE

    K Number: K122064 · Decision May 7, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    100
    Registration Numbers
    100
    Same Product Code
    214
    Applicant Total
    11
    Review Days
    298

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    Basic Information

    Device Name
    FORSURE ONE STEP BUPRENORPHINE CUP TEST DEVICE
    K Number
    K122064
    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
    July 13, 2012
    Decision Date
    May 7, 2013
    Product Code
    DJG
    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
    DJG Enzyme Immunoassay, Opiates

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    K061617 FORSURE ONE STEP DIP & READ (X) DRUG SCREEN TEST
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    K052882 FORSURE RAPID ONE STEP MULTIPLE(X) ABUSE DRUG SCREEN TEST CUP DEVICE
    K052208 GLUCOSE PILOT
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