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

    BioSieve Multi-Drug Urine Test Panel;BioSieve Multi-Drug Urine Home Test Panel

    K Number: K261280 · Decision May 22, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    49
    Registration Numbers
    49
    Same Product Code
    29
    Applicant Total
    10
    Review Days
    35

    Basic Information

    Device Name
    BioSieve Multi-Drug Urine Test Panel;BioSieve Multi-Drug Urine Home Test Panel
    K Number
    K261280
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3100
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Vivachek Biotech (Hangzhou) Co., Ltd.
    Date Received
    April 17, 2026
    Decision Date
    May 22, 2026
    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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