BEUDAMED
    FDA Registration Active 🇺🇸 United States

    FreeStyle InsuLinx Blood Glucose Monitoring System

    Reg #: 2954323 · FEI: 3002803444 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    2

    Registration Details

    Registration Name
    ABBOTT DIABETES CARE INC.
    Registration Number
    2954323
    FEI Number
    3002803444
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    1360 SOUTH LOOP RD.
    City
    ALAMEDA
    State
    CA
    ZIP
    94502
    Country
    US

    Regulatory Submissions

    510(k) Number
    K152328

    Owner / Operator

    Firm Name
    ABBOTT LABORATORIES
    Operator Number
    1415939
    Address
    100 ABBOTT PARK RD., D-03Q3, AP52-1
    City
    Abbott Park
    State
    IL
    Postal Code
    60064
    Country
    US

    Products

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

    Proprietary Names

    FreeStyle InsuLinx Blood Glucose Monitoring System

    Establishment Types

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