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

    Deepblue Multi-Drug Urine Test Cup; Deepblue Home Muti-Drug Urine Test Cup

    K Number: K250803 · Decision Apr 15, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    57
    Registration Numbers
    57
    Same Product Code
    22
    Applicant Total
    1
    Review Days
    29

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    Basic Information

    Device Name
    Deepblue Multi-Drug Urine Test Cup; Deepblue Home Muti-Drug Urine Test Cup
    K Number
    K250803
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3650
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Anhui Deepblue Medical Technological Co., Ltd.
    Date Received
    March 17, 2025
    Decision Date
    April 15, 2025
    Product Code
    NGL
    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
    NGL Test, Opiates, Over The Counter

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