BEUDAMED
    FDA Registration Active 🇨🇦 Canada

    LCX - KIT, TEST, PREGNANCY, HCG, OVER THE COUNTER

    Reg #: 3005445066 · FEI: 3005445066 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    2
    Establishment Types
    2
    Classifications
    2

    Registration Details

    Registration Name
    ARTRON LABORATORIES INC.
    Registration Number
    3005445066
    FEI Number
    3005445066
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    3938 North Fraser Way
    City
    Burnaby British Columbia
    Country
    CA

    Regulatory Submissions

    510(k) Number
    K060019

    Owner / Operator

    Firm Name
    Artron Laboratories Inc.
    Operator Number
    10045485
    Address
    3938 North Fraser Way
    City
    Burnaby
    State
    British Columbia
    Postal Code
    V5J 5H6
    Country
    CA

    US Agent

    Business Name
    Registrar Corp
    Contact Name
    David Lennarz
    Address
    144 Research Dr
    City
    Hampton
    State
    VA
    ZIP
    23666
    Country
    US
    Email
    [email protected]
    Phone
    757 2240177

    Products

    Device Name Product Code
    Kit, Test, Pregnancy, Hcg, Over The Counter LCX
    Visual, Pregnancy Hcg, Prescription Use JHI

    Proprietary Names

    LCX - KIT, TEST, PREGNANCY, HCG, OVER THE COUNTER JHI - Visual, pregnancy hCG, prescription use

    Establishment Types

    Export Device to the United States But Perform No Other Operation on Device Manufacture Medical Device