BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Clarity Glucose Meter

    Reg #: 3004043187 · FEI: 3004043187 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    Clarity Diagnostics, LLC
    Registration Number
    3004043187
    FEI Number
    3004043187
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    1060 Holland Dr STE A
    City
    BOCA RATON
    State
    FL
    ZIP
    33487
    Country
    US

    Regulatory Submissions

    510(k) Number
    K062829

    Owner / Operator

    Firm Name
    33487
    Operator Number
    9057600
    Address
    1060 Holland Dr STE A, --
    City
    Boca Raton
    State
    FL
    Postal Code
    33487
    Country
    US
    Correspondent
    Richard - Simpson

    Products

    Device Name Product Code
    Glucose Oxidase, Glucose CGA
    System, Test, Blood Glucose, Over The Counter NBW

    Proprietary Names

    Clarity Glucose Meter

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198