BEUDAMED
    FDA Registration Active 🇯🇵 Japan

    ARCHITECT iValproic Acid Assay

    Reg #: 3003871639 · FEI: 3003871639 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    DENKA CO., LTD.
    Registration Number
    3003871639
    FEI Number
    3003871639
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    1359-1, KAGAMIDA, KIGOSHI
    City
    GOSEN-SHI Niigata
    Country
    JP

    Regulatory Submissions

    510(k) Number
    K090358

    Owner / Operator

    Firm Name
    DENKA CO., LTD.
    Operator Number
    9053049
    Address
    1359-1, KAGAMIDA, KIGOSHI
    City
    GOSEN-SHI
    State
    Niigata
    Postal Code
    959-1695
    Country
    JP

    Products

    Device Name Product Code
    Enzyme Immunoassay, Valproic Acid LEG
    Calibrators, Drug Specific DLJ

    Proprietary Names

    ARCHITECT iValproic Acid Assay

    Establishment Types

    Manufacture Medical Device