BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Q.STEPS Cholesterol Meter System

    Reg #: 3010830834 · FEI: 3004525092 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    BiometerPlus USA, Inc.
    Registration Number
    3010830834
    FEI Number
    3004525092
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    48531 Warm Springs Blvd., #416
    City
    Fremont
    State
    CA
    ZIP
    94539
    Country
    US

    Regulatory Submissions

    510(k) Number
    K033627

    Owner / Operator

    Firm Name
    BiometerPlus USA, Inc.
    Operator Number
    10046647
    Address
    48531 Warm Springs Blvd., #416
    City
    Fremont
    State
    CA
    Postal Code
    94539
    Country
    US
    Correspondent
    Jian Zhou

    Products

    Device Name Product Code
    Single (Specified) Analyte Controls (Assayed And Unassayed) JJX
    Glucose Oxidase, Glucose CGA

    Proprietary Names

    Q.STEPS Cholesterol Meter System Q.Steps G/C Monitoring system(Glucose/TC); Q.Steps Glucose Meter system

    Establishment Types

    Manufacture Medical Device