BEUDAMED
    FDA Registration Active 🇯🇵 Japan

    PATHFAST hsCRP

    Reg #: 3014353045 · FEI: 3014353045 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    PHC Corporation
    Registration Number
    3014353045
    FEI Number
    3014353045
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    15F DAI-ICHI LIFE HIBIYA FIRST, 1-13-2 Yurakucho
    City
    Chiyoda-ku Tokyo
    Country
    JP

    Regulatory Submissions

    510(k) Number
    K083412

    Owner / Operator

    Firm Name
    PHC Corporation
    Operator Number
    9052268
    Address
    2131-1 MINAMIGATA
    City
    TOON
    State
    Ehime
    Postal Code
    791-0395
    Country
    JP

    US Agent

    Business Name
    PHC Corporation Of North America
    Contact Name
    Steven Hubbard
    Address
    1300 MICHAEL DR , STE A
    City
    Wood Dale
    State
    IL
    ZIP
    60191
    Country
    US
    Email
    [email protected]
    Phone
    551 4829284

    Products

    Device Name Product Code
    System, Test, C-Reactive Protein DCN
    Calibrator, Secondary JIT

    Proprietary Names

    PATHFAST hsCRP

    Establishment Types

    Export Device to the United States But Perform No Other Operation on Device