BEUDAMED
    FDA Registration Active 🇺🇸 United States

    IMMULITE 2000 Systems

    Reg #: 3014717638 · FEI: 3014717638 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    TN MICHIGAN, LLC
    Registration Number
    3014717638
    FEI Number
    3014717638
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    1390 Industrial Park Drive
    City
    Sault Sainte Marie
    State
    MI
    ZIP
    49783
    Country
    US

    Regulatory Submissions

    510(k) Number
    K970227

    Owner / Operator

    Firm Name
    TN Michigan, LLC
    Operator Number
    10075464
    Address
    1390 Industrial Park Drive
    City
    Sault Sainte Marie
    State
    MI
    Postal Code
    49783
    Country
    US
    Correspondent
    Mark C Mettner

    Products

    Device Name Product Code
    Analyzer, Chemistry (Photometric, Discrete), For Clinical Use JJE

    Proprietary Names

    IMMULITE 2000 Systems

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)