BEUDAMED
    FDA Registration Active 🇯🇵 Japan

    EIKEN CHEMICAL CO., LTD.

    Reg #: 9611917 · FEI: 3009431614 · Expires 2026
    View on FDA
    Products
    2
    Proprietary Names
    4
    Establishment Types
    1
    Classifications
    2

    Research this establishment in seconds

    The Research Assistant profiles FDA-registered establishments — listings, owners, related facilities — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Registration Details

    Registration Name
    EIKEN CHEMICAL CO., LTD.
    Registration Number
    9611917
    FEI Number
    3009431614
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    4-6 Kanda Surugadai
    City
    Chiyoda-ku Tokyo
    Country
    JP

    Regulatory Submissions

    510(k) Number
    K041408

    Owner / Operator

    Firm Name
    EIKEN CHEMICAL CO., LTD.
    Operator Number
    8031541
    Address
    4-6 Kanda Surugadai, --
    City
    Chiyoda-ku
    State
    Tokyo
    Postal Code
    101-0062
    Country
    JP
    Correspondent
    Tadashi - Yasuda

    US Agent

    Business Name
    Jataki Company LLC
    Contact Name
    Derek Wessman
    Address
    3300 N Triumph Blvd Suite 100
    City
    Lehi
    State
    UT
    ZIP
    84043
    Country
    US
    Email
    [email protected]
    Phone
    801 6569278

    Products

    Device Name Product Code
    Automated Occult Blood Analyzer OOX
    Reagent, Occult Blood KHE

    Proprietary Names

    OC-Auto Micro 80 FOB Test OC-Auto Sensor io iFOB Test OC-Sensor DIANA iFOB Test OC-Light S FIT

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility