BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Accu-CHEK GUIDE 2-LEVEL CONTROLS US

    Reg #: 3011393376 · FEI: 3011393376 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    27
    Establishment Types
    3
    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
    K160944

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

    Proprietary Names

    Accu-CHEK GUIDE 2-LEVEL CONTROLS US Accu-Chek Guide Test Strip 50 CT 36/CS ACCU-CHEK GUIDE 50CT STRIP 36/CS Accu-Chek Guide Test Strip 10 CT 36/CS ACCU-CHEK GUIDE MAIL ORDER 50 CT Accu-Chek Guide Test Strip 100 CT 24/CS ACCU-CHEK GUIDE 10CT STRIP 36/CS ACCU-CHEK GUIDE MG/DL METER 923 (US) ACCU CHEK GUIDE HCP SAMPLE LAUNCH BOX ACCU-CHECK Guide Blood Glucose Monitoring System Accu-Chek Guide Retail Kit mg/dL (US) ACCU-CHEK GUIDE METER ONLY MG/DL US ACCU-CHEK GUIDE MG/DL M-O ACCU-CHEK GUIDE MG/DL KIT ACCU-CHEK Guide Control Solutions ACCU-CHEK GUIDE 50CT HN 36/CS ACCU-CHEK GUIDE MED BEN 50 CT ACCU-CHEK GUIDE 2-LEVEL CONTROLS US ACCU-CHEK GUIDE 100CT STRIP 24/CS ACCU-CHEK GUIDE RETAIL KIT MG/DL ACCU-CHEK GUIDE 25CT STRIP 36/CS ACCU-CHEK GUIDE RETAIL KIT FCN MG/DL US Accu-Chek Guide Blood Glucose Monitoring System Accu-Chek Guide Sample Kit FCN MG/DL US ACCU-CHEK GUIDE CASH VALUE KIT SC MG/DL ACCU-CHEK GUIDE CASH US 30CT STRIP ACCU-CHEK GUIDE CASH US 60CT STRIP

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility Repack or Relabel Medical Device Manufacture Medical Device