BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    LZI Fentanyl III Enzyme Immunoassay

    K Number: K251634 · Decision Jun 18, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    106
    Registration Numbers
    106
    Same Product Code
    209
    Applicant Total
    48
    Review Days
    20

    Basic Information

    Device Name
    LZI Fentanyl III Enzyme Immunoassay
    K Number
    K251634
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    862.3650
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Lin-Zhi International, Inc.
    Date Received
    May 29, 2025
    Decision Date
    June 18, 2025
    Product Code
    DJG
    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
    DJG Enzyme Immunoassay, Opiates

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    Other Clearances by Lin-Zhi International, Inc.

    K Number Device Name
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    K181159 LZI Fentanyl Enzyme Immunoassay
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    K170416 LZI Methadone Metabolite Enzyme Immunoassay, LZI Methadone Metabolite (100 and 300) Calibrators
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    K141055 LZI HYDROCODONE; ENZYME IMMUNOASSAY, CALIBRATORS; (5ML), (15ML); CONTROLS; (5ML), (15ML)
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