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

    BIOEASY Multi-Drug Test Cup

    K Number: K182530 · Decision Nov 9, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    49
    Registration Numbers
    49
    Same Product Code
    29
    Applicant Total
    5
    Review Days
    56

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    Basic Information

    Device Name
    BIOEASY Multi-Drug Test Cup
    K Number
    K182530
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3100
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Shenzhen Bioeasy Biotechnology Co., Ltd.
    Date Received
    September 14, 2018
    Decision Date
    November 9, 2018
    Product Code
    NFT
    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
    NFT Test, Amphetamine, Over The Counter

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    Other Clearances by Shenzhen Bioeasy Biotechnology Co., Ltd.

    K Number Device Name
    K230238 BIOEASY™ U-Catch MAX Multi-Drug Test Cup, BIOEASY™ U-Catch MAX Multi-Drug Test Cup Rx
    K193480 BIOEASY Multi-Drug Test Cup
    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