BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Oxycodone Enzyme Immunoassay

    Reg #: 3003610499 · FEI: 3003610499 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    3
    Establishment Types
    1
    Classifications
    3

    Registration Details

    Registration Name
    LIN-ZHI INTERNATIONAL, INC.
    Registration Number
    3003610499
    FEI Number
    3003610499
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    2945 Oakmead Village Ct
    City
    Santa Clara
    State
    CA
    ZIP
    95051
    Country
    US

    Regulatory Submissions

    510(k) Number
    K120763

    Owner / Operator

    Firm Name
    LIN-ZHI INTERNATIONAL, INC.
    Operator Number
    9049436
    Address
    2945 Oakmead Village Court, --
    City
    Santa Clara
    State
    CA
    Postal Code
    95051
    Country
    US
    Correspondent
    MARIE LIN

    Products

    Device Name Product Code
    Drug Specific Control Materials LAS
    Calibrators, Drug Specific DLJ
    Enzyme Immunoassay, Opiates DJG

    Proprietary Names

    Oxycodone Enzyme Immunoassay Oxycodone DAU Controls Oxycodone DAU Calibrators

    Establishment Types

    Manufacture Medical Device