BEUDAMED
    FDA Registration Active 🇯🇵 Japan

    Calibrator 80

    Reg #: 3003422726 · FEI: 3003422726 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    3

    Registration Details

    Registration Name
    ARKRAY Factory, Inc.
    Registration Number
    3003422726
    FEI Number
    3003422726
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    1480 Koji, Konan-cho
    City
    Koka-shi Shiga
    Country
    JP

    Regulatory Submissions

    510(k) Number
    K162822

    Owner / Operator

    Firm Name
    ARKRAY, INC.
    Operator Number
    8030316
    Address
    8260 NW 27th Street, Suite 403
    City
    Miami
    State
    FL
    Postal Code
    33122
    Country
    US

    US Agent

    Business Name
    ARKRAY Factory USA, Inc.
    Contact Name
    Tom Speikers
    Address
    8260 NW 27th Street, Suite 403
    City
    Miami
    State
    FL
    ZIP
    33122
    Country
    US
    Email
    [email protected]
    Phone
    952 6463168

    Products

    Device Name Product Code
    Hemoglobin A1c Test System PDJ
    Calibrator, Secondary JIT
    Assay, Glycosylated Hemoglobin LCP

    Proprietary Names

    Calibrator 80 ADAMS A1c HA-8180V

    Establishment Types

    Manufacture Medical Device