BEUDAMED
    FDA Registration Active 🇺🇸 United States

    ACCU-CHEK SMART VIEW 50CT STRIP 36/CS

    Reg #: 3011393376 · FEI: 3011393376 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    18
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    ROCHE DIABETES CARE, INC.
    Registration Number
    3011393376
    FEI Number
    3011393376
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    9115 Hague Road
    City
    Indianapolis
    State
    IN
    ZIP
    46250
    Country
    US

    Regulatory Submissions

    510(k) Number
    K113137

    Owner / Operator

    Firm Name
    Roche Diagnostics Operations Inc.
    Operator Number
    9039767
    Address
    9115 Hague Road
    City
    Indianapolis
    State
    IN
    Postal Code
    46250
    Country
    US
    Correspondent
    Brian Frazier

    Products

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

    Proprietary Names

    ACCU-CHEK SMART VIEW 50CT STRIP 36/CS ACCU-CHEK NANO SAMPLE KIT DSGNR 16/CASE ACCU-CHEK SMART VIEW 25CT STRIP 36/CS ACCU-CHEK SMART VIEW CONTROL 6/CS ACCU-CHEK NANO SAMPLE KIT 16/CASE ACCU-CHEK SMART VIEW 100CT STRIP 24/CS ACCU-CHEK SMART VIEW 25 + 5 STRIP 36/CS ACCU-CHEK SMART VIEW 10CT STRIP ACCU-CHEK NANO RETAIL KIT DSGNR 8/CASE ACCU-CHEK NANO METER ONLY ACCU-CHEK NANO RETAIL KIT 8/CASE ACCU-CHEK SMART VIEW MED BEN STRIP 36/CS ACCU-CHEK SmartView Test Strip ACCU-CHEK Nano SmartView Blood Glucose Monitoring System ACCU-CHEK SMART VIEW CONTROL 2 ACCU-CHEK SMART VIEW MAIL ORDER STRIP 36 ACCU-CHEK Nano Meter ACCU-CHEK SmartView Control Solutions

    Establishment Types

    Manufacture Medical Device