BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Calibrator 80

    Reg #: 1832816 · FEI: 1832816 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    3

    Registration Details

    Registration Name
    ARKRAY FACTORY USA, INC.
    Registration Number
    1832816
    FEI Number
    1832816
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    8260 NW 27th Street, Suite 403
    City
    Miami
    State
    FL
    ZIP
    33122
    Country
    US

    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
    Correspondent
    TOM - SPEIKERS

    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

    Complaint File Establishment per 21 CFR 820.198