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

    CR3 KEYLESS SPLIT SAMPLE CUP AMPHETAMINE-COCAINE

    K Number: K141532 · Decision Jul 14, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    96
    Registration Numbers
    96
    Same Product Code
    224
    Applicant Total
    43
    Review Days
    34

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    Basic Information

    Device Name
    CR3 KEYLESS SPLIT SAMPLE CUP AMPHETAMINE-COCAINE
    K Number
    K141532
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3100
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Guangzhou Wondfo Biotech Co., Ltd.
    Date Received
    June 10, 2014
    Decision Date
    July 14, 2014
    Product Code
    DKZ
    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
    DKZ Enzyme Immunoassay, Amphetamine

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