BEUDAMED
    FDA Registration Active 🇺🇸 United States

    OPTI CCA-TS Urea Glucose

    Reg #: 3004102403 · FEI: 3004102403 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    3
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    OPTI MEDICAL SYSTEMS INC.
    Registration Number
    3004102403
    FEI Number
    3004102403
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    235 Hembree Park Dr
    City
    ROSWELL
    State
    GA
    ZIP
    30076
    Country
    US

    Regulatory Submissions

    510(k) Number
    K993837

    Owner / Operator

    Firm Name
    IDEXX LABORATORIES INC.
    Operator Number
    9097732
    Address
    ONE IDEXX DR., --
    City
    Westbrook
    State
    ME
    Postal Code
    04092
    Country
    US

    Products

    Device Name Product Code
    Glucose Oxidase, Glucose CGA
    Electrode, Ion Specific, Urea Nitrogen CDS

    Proprietary Names

    OPTI CCA-TS Urea Glucose OPTI CCA-TS Analyzer OPTI CCA Analyzer

    Establishment Types

    Manufacture Medical Device