BEUDAMED
    FDA Registration Active 🇨🇦 Canada

    DYLAN LUCAS INTERNATIONAL INC

    Reg #: 3011689956 · FEI: 3011689956 · Expires 2025
    View on FDA
    Products
    11
    Proprietary Names
    0
    Establishment Types
    1
    Classifications
    11

    Registration Details

    Registration Name
    DYLAN LUCAS INTERNATIONAL INC
    Registration Number
    3011689956
    FEI Number
    3011689956
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    101 Innovation Drive, Unit 4
    City
    Vaughan Ontario
    Country
    CA

    Regulatory Submissions

    510(k) Number
    K992257

    Owner / Operator

    Firm Name
    Dylan Lucas International Inc
    Operator Number
    10054202
    Address
    67 Heintzman Cres
    City
    Vaughan
    State
    Ontario
    Postal Code
    L6A4T1
    Country
    CA
    Correspondent
    Eli Osipov

    Products

    Device Name Product Code
    Blood, Occult, Colorimetric, In Urine JIO
    Method, Enzymatic, Glucose (Urinary, Non-Quantitative) JIL
    Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.) JJB
    Dye-Indicator, Ph (Urinary, Non-Quantitative) CEN
    Indicator Method, Protein Or Albumin (Urinary, Non-Quant.) JIR
    Test, Urine Leukocyte LJX
    Nitroprusside, Ketones (Urinary, Non-Quant.) JIN
    Enzymatic Method, Creatinine JFY
    Refractometer For Clinical Use JRE
    Diazo (Colorimetric), Nitrite (Urinary, Non-Quant) JMT
    Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.) CDM

    Establishment Types

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