BEUDAMED
    FDA Registration Active 🇯🇵 Japan

    Lucica Glycated Albumin-L

    Reg #: 3008178161 · FEI: 3008178161 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    KAINOS LABORATORIES, INC., KASAMA FACTORY
    Registration Number
    3008178161
    FEI Number
    3008178161
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    3-5 Aza Yarokuuchi Inada
    City
    Kasama Ibaraki
    Country
    JP

    Regulatory Submissions

    510(k) Number
    K170147

    Owner / Operator

    Firm Name
    KAINOS LABORATORIES INC
    Operator Number
    10030967
    Address
    38-18, Hongo 2-Chome,
    City
    Bunkyo-Ku
    State
    Tokyo
    Postal Code
    113-0033
    Country
    JP
    Correspondent
    Kou Horii

    US Agent

    Business Name
    Emergo Global Representation LLC
    Contact Name
    Yong Sun
    Address
    2500 Bee Cave Rd., Bldg. 1, Ste. 300
    City
    Austin
    State
    TX
    ZIP
    78746
    Country
    US
    Email
    [email protected]
    Phone
    512 3279997

    Products

    Device Name Product Code
    Assay, Glycosylated Hemoglobin LCP

    Proprietary Names

    Lucica Glycated Albumin-L

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)