BEUDAMED
    FDA Registration Active 🇺🇸 United States

    FreeStyle Lancet

    Reg #: 2954323 · FEI: 3002803444 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    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
    K221433

    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
    Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature QRK
    Multiple Use Blood Lancet For Single Patient Use Only QRL

    Proprietary Names

    FreeStyle Lancet

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198