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

    BIOEASY Multi-Drug Test Cup

    K Number: K193480 · Decision Jan 31, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    57
    Registration Numbers
    57
    Same Product Code
    22
    Applicant Total
    5
    Review Days
    46

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    Basic Information

    Device Name
    BIOEASY Multi-Drug Test Cup
    K Number
    K193480
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3650
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Shenzhen Bioeasy Biotechnology Co., Ltd.
    Date Received
    December 16, 2019
    Decision Date
    January 31, 2020
    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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    Other Clearances by Shenzhen Bioeasy Biotechnology Co., Ltd.

    K Number Device Name
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    K192515 BIOEASY Marijuana Test Dip Card 40, BIOEASY Marijuana Test Dip Card 20, BIOEASY Marijuana Test Strip 40, BIOEASY Marijuana Test Strip 20
    K192301 BIOEASY Marijuana Test Dip Card, BIOEASY Marijuana Test Strip
    K182530 BIOEASY Multi-Drug Test Cup