BEUDAMED
    FDA Registration Active 🇺🇸 United States

    microdot Xtra

    Reg #: 3008700497 · FEI: 3008700497 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    3

    Registration Details

    Registration Name
    Cambridge Sensors USA, LLC.
    Registration Number
    3008700497
    FEI Number
    3008700497
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    23866 W Industrial Dr N
    City
    Plainfield
    State
    IL
    ZIP
    60585
    Country
    US

    Regulatory Submissions

    510(k) Number
    K083273

    Owner / Operator

    Firm Name
    Cambridge Sensors USA, LLC.
    Operator Number
    10042320
    Address
    23866 W Industrial Drive N
    City
    Plainfield
    State
    IL
    Postal Code
    60585
    Country
    US
    Correspondent
    Chris W Sullivan

    Products

    Device Name Product Code
    Single (Specified) Analyte Controls (Assayed And Unassayed) JJX
    System, Test, Blood Glucose, Over The Counter NBW
    Glucose Dehydrogenase, Glucose LFR

    Proprietary Names

    microdot Xtra

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198