BEUDAMED
    FDA Registration Active 🇺🇸 United States

    easy@Home Urinary Tract Infection Test

    Reg #: 2531491 · FEI: 3003516723 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    4
    Establishment Types
    2
    Classifications
    2

    Registration Details

    Registration Name
    ACON LABORATORIES, INC.
    Registration Number
    2531491
    FEI Number
    3003516723
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    9440 Carroll Park Drive
    City
    SAN DIEGO
    State
    CA
    ZIP
    92121
    Country
    US

    Regulatory Submissions

    510(k) Number
    K063295

    Owner / Operator

    Firm Name
    ACON Laboratories, Inc.
    Operator Number
    9063887
    Address
    5850 Oberlin Drive, #340
    City
    San Diego
    State
    CA
    Postal Code
    92121
    Country
    US
    Correspondent
    Catherine Shi

    Products

    Device Name Product Code
    Test, Urine Leukocyte LJX
    Diazo (Colorimetric), Nitrite (Urinary, Non-Quant) JMT

    Proprietary Names

    easy@Home Urinary Tract Infection Test HealthyMe Urinary Tract Infection Test Strips Mission UTI Urinary Tract Infection Test Strips Urinox Urinary Tract Infection Test Strips

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device