BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇳 China

    CR3 Keyless Split Sample Cup Morphine - Methamphetamine

    K Number: K150602 · Decision Apr 7, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    20
    Registration Numbers
    20
    Same Product Code
    3
    Applicant Total
    1
    Review Days
    28

    Basic Information

    Device Name
    CR3 Keyless Split Sample Cup Morphine - Methamphetamine
    K Number
    K150602
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3640
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    GUANGZHOU WONDFO BIOTECH CO., LTD.
    Date Received
    March 10, 2015
    Decision Date
    April 7, 2015
    Product Code
    DNK
    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
    DNK Thin Layer Chromatography, Morphine

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