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

    LYHER® Oral fluid Multi-Drug Test Kit (Cube)

    K Number: K240287 · Decision Mar 18, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    53
    Registration Numbers
    53
    Same Product Code
    30
    Applicant Total
    3
    Review Days
    411

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    Basic Information

    Device Name
    LYHER® Oral fluid Multi-Drug Test Kit (Cube)
    K Number
    K240287
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3610
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Hangzhou Laihe Biotech Co., Ltd.
    Date Received
    February 1, 2024
    Decision Date
    March 18, 2025
    Product Code
    DJC
    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
    DJC Thin Layer Chromatography, Methamphetamine

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    Other Clearances by Hangzhou Laihe Biotech Co., Ltd.

    K Number Device Name
    K232604 LYHER® Urine Marijuana (THC) Test Kit (Strip), LYHER® Urine Marijuana (THC) Test Kit (Cassette)
    K232597 LYHER® Urine Multi-Drug Test Kit(Cup), LYHER® Urine Multi-Drug Test Kit(Cassette), LYHER® Urine Multi-Drug Test Kit(Dipcard)