BEUDAMED
    FDA Registration Active 🇯🇵 Japan

    G8 AUTOMATED HPLC ANALYZER

    Reg #: 3004529019 · FEI: 3004529019 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    Tosoh Hi-Tec, Inc.
    Registration Number
    3004529019
    FEI Number
    3004529019
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    1-37 Fukugawa Minami-machi, Shunan-shi
    City
    Yamaguchi
    Country
    JP

    Regulatory Submissions

    510(k) Number
    K071132

    Owner / Operator

    Firm Name
    TOSOH BIOSCIENCE
    Operator Number
    8031673
    Address
    3600 Gantz Road
    City
    Grove City
    State
    OH
    Postal Code
    43123
    Country
    US
    Correspondent
    Joshua D Levin

    US Agent

    Business Name
    Tosoh Bioscience Inc.
    Contact Name
    Dave Wurtz
    Address
    3600 Gantz Road
    City
    Grove City
    State
    OH
    ZIP
    43123
    Country
    US
    Email
    [email protected]
    Phone
    415 6354762

    Products

    Device Name Product Code
    Calibrator, Primary JIS
    Assay, Glycosylated Hemoglobin LCP

    Proprietary Names

    G8 AUTOMATED HPLC ANALYZER

    Establishment Types

    Manufacture Medical Device