BEUDAMED
    FDA Registration Active 🇺🇸 United States

    ACCU-CHEK Inform II Blood Glucose Monitoring System

    Reg #: 3011393376 · FEI: 3011393376 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    11
    Establishment Types
    1
    Classifications
    3

    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
    K121679

    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
    Single (Specified) Analyte Controls (Assayed And Unassayed) JJX

    Proprietary Names

    ACCU-CHEK Inform II Blood Glucose Monitoring System ACCU-CHEK Inform II Test Strip ACCU-CHEK Inform II Control Solutions ACCU-CHEK Inform II Meter Kit + RF ACCU-CHEK Inform II Meter ACCU-CHEK Inform II Linearity Test Kit ACCU-CHEK INFORM II CNTRL US 6/CS ACCU-HEK LINEARITY KIT U.S. ACCU-CHECK INFORM II US 50CT 72/CS F2 ACCU-CHEK Inform II System A/C Inform II Base Unit Kit

    Establishment Types

    Manufacture Medical Device