BEUDAMED
    FDA Registration Active 🇹🇼 Taiwan

    TysonBio AC500 Blood Glucose Monitoring System

    Reg #: 3003132490 · FEI: 3003132490 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    4
    Establishment Types
    1
    Classifications
    3

    Registration Details

    Registration Name
    TYSON BIORESEARCH, INC.
    Registration Number
    3003132490
    FEI Number
    3003132490
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    5F., No. 16, 18, 20, 22, Kedong 3rd Rd.
    City
    Zhunan Township Miaoli
    Country
    TW

    Regulatory Submissions

    510(k) Number
    K123087

    Owner / Operator

    Firm Name
    TYSON BIORESEARCH, INC.
    Operator Number
    9047348
    Address
    5F., No. 16, 18, 20, 22, Kedong 3rd Rd.,
    City
    Zhunan Township, Miaoli County
    State
    TW-NOTA
    Postal Code
    35053
    Country
    TW
    Correspondent
    Roger - Lee

    US Agent

    Business Name
    mdi Consultants, Inc.
    Contact Name
    Diane Furnari
    Address
    55 Northern Blvd., Great Neck,
    City
    Allenwood
    State
    NY
    ZIP
    11021
    Country
    US
    Email
    [email protected]
    Phone
    516 4829001

    Products

    Device Name Product Code
    Glucose Oxidase, Glucose CGA
    System, Test, Blood Glucose, Over The Counter NBW
    Single (Specified) Analyte Controls (Assayed And Unassayed) JJX

    Proprietary Names

    TysonBio AC500 Blood Glucose Monitoring System ONE-CARE (Model AC500) Blood Glucose Monitoring System ONE-CARE PRO (Model AC500 PRO) Blood Glucose Monitoring System TysonBio AC500 PRO Blood Glucose Monitoring System

    Establishment Types

    Manufacture Medical Device