BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Bayer Contour TS

    Reg #: 1181121 · FEI: 1181121 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    5
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    Fisher Diagnostics
    Registration Number
    1181121
    FEI Number
    1181121
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    8365 VALLEY PIKE
    City
    MIDDLETOWN
    State
    VA
    ZIP
    22645
    Country
    US

    Regulatory Submissions

    510(k) Number
    K062058

    Owner / Operator

    Firm Name
    Thermo Fisher Scientific
    Operator Number
    2517925
    Address
    168 Third Avenue, --
    City
    Waltham
    State
    MA
    Postal Code
    02451
    Country
    US

    Products

    Device Name Product Code
    Glucose Dehydrogenase, Glucose LFR
    System, Test, Blood Glucose, Over The Counter NBW

    Proprietary Names

    Bayer Contour TS Contour High Control Contour Normal Bulk, Contour Normal Single Control Countour Normal Control Contour Low Control

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)