BEUDAMED
    FDA Registration Active 🇺🇸 United States

    HISCL TSH Assay Kit

    Reg #: 3009711478 · FEI: 3009711478 · Expires 2025
    View on FDA
    Products
    4
    Proprietary Names
    4
    Establishment Types
    1
    Classifications
    4

    Registration Details

    Registration Name
    Sysmex America, Inc.
    Registration Number
    3009711478
    FEI Number
    3009711478
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    577 Aptakisic Rd
    City
    Lincolnshire
    State
    IL
    ZIP
    60069
    Country
    US

    Regulatory Submissions

    510(k) Number
    K160541

    Owner / Operator

    Firm Name
    SYSMEX CORPORATION
    Operator Number
    9014170
    Address
    4-4-4 TAKATSUKADAI, NISHI-KU
    City
    KOBE
    State
    JP-NOTA
    Postal Code
    651-2271
    Country
    JP

    Products

    Device Name Product Code
    Radioimmunoassay, Thyroid-Stimulating Hormone JLW
    Analyzer, Chemistry (Photometric, Discrete), For Clinical Use JJE
    Multi-Analyte Controls, All Kinds (Assayed) JJY
    Calibrator, Secondary JIT

    Proprietary Names

    HISCL TSH Assay Kit HISCL Immuno Multi Control Automated Immunoassay System HISCL-800 HISCL TSH Calibrator

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198