BEUDAMED
    FDA Registration Active 🇨🇦 Canada

    AmnioTest Colour Cards

    Reg #: 8010383 · FEI: 1000354384 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    4
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    pro-lab incorporated
    Registration Number
    8010383
    FEI Number
    1000354384
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    20 Mural Street, Unit #4
    City
    Richmond Hill Ontario
    Country
    CA

    Regulatory Submissions

    510(k) Number
    K914419

    Owner / Operator

    Firm Name
    PRO-LAB, INC.
    Operator Number
    8010383
    Address
    20 MURAL ST., UNIT #4
    City
    RICHMOND HILL,
    State
    Ontario
    Postal Code
    L4B 1K3
    Country
    CA

    US Agent

    Business Name
    Pro-Lab Incorporated
    Contact Name
    Robert J Rae
    Address
    1301 Blue Ridge Dr, Suite 101
    City
    Georgetown
    State
    TX
    ZIP
    78626
    Country
    US
    Email
    [email protected]
    Phone
    512 8329145

    Products

    Device Name Product Code
    Sampler, Amniotic Fluid (Amniocentesis Tray) HIO

    Proprietary Names

    AmnioTest Colour Cards AmnioTest (20 Pack) Bulk dipped AmnioTest swabs AmnioTest (100 pack)

    Establishment Types

    Manufacture Medical Device