BEUDAMED
    FDA Registration Active 🇯🇵 Japan

    GLYCOMARK

    Reg #: 3002807722 · FEI: 3002807722 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    3

    Registration Details

    Registration Name
    TAKASAKI PLANT, NIPPON KAYAKU CO., LTD.
    Registration Number
    3002807722
    FEI Number
    3002807722
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    239, IWAHANAMACHI
    City
    TAKASAKI-SHI Gunma
    Country
    JP

    Regulatory Submissions

    510(k) Number
    K031604

    Owner / Operator

    Firm Name
    NIPPON KAYAKU CO., LTD.
    Operator Number
    9066715
    Address
    1-1, MARUNOUCHI 2-CHOME, --
    City
    CHIYODA-KU
    State
    Tokyo
    Postal Code
    100-0005
    Country
    JP

    US Agent

    Business Name
    PRECISION DIABETES, INC.
    Contact Name
    Eric Button
    Address
    5540 Centerview Drive, Suite 200
    City
    Raleigh
    State
    NC
    ZIP
    27606
    Country
    US
    Email
    [email protected]
    Phone
    888 7440221

    Products

    Device Name Product Code
    Single (Specified) Analyte Controls (Assayed And Unassayed) JJX
    Assay, 1,5-Anhydroglucitol (15ag) NOZ
    Calibrator, Primary JIS

    Proprietary Names

    GLYCOMARK

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)