BEUDAMED
    FDA Registration Active 🇯🇵 Japan

    PATHFAST Myo-II

    Reg #: 3029973107 · FEI: 3029973107 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    3
    Establishment Types
    2
    Classifications
    3

    Registration Details

    Registration Name
    PHC Corporation
    Registration Number
    3029973107
    FEI Number
    3029973107
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    1460-6 Aza-Mitodai, Mito
    City
    Tako-machi Katori-gun Chiba
    Country
    JP

    Regulatory Submissions

    510(k) Number
    K081360

    Owner / Operator

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

    Products

    Device Name Product Code
    Myoglobin, Antigen, Antiserum, Control DDR
    Calibrator, Secondary JIT
    Fluorometric Method, Cpk Or Isoenzymes JHX

    Proprietary Names

    PATHFAST Myo-II PATHFAST CK-MB-II PATHFAST Sample Diluent 1

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility Complaint File Establishment per 21 CFR 820.198