BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Actalyke XL Analyzer

    Reg #: 1644474 · FEI: 1000116989 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    HELENA LABORATORIES, CORP.
    Registration Number
    1644474
    FEI Number
    1000116989
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    3795 WASHINGTON BLVD.
    City
    BEAUMONT
    State
    TX
    ZIP
    77705
    Country
    US

    Regulatory Submissions

    510(k) Number
    K020914

    Owner / Operator

    Firm Name
    HELENA LABORATORIES, CORP.
    Operator Number
    1618982
    Address
    1530 LINDBERGH DRIVE
    City
    Beaumont
    State
    TX
    Postal Code
    77707
    Country
    US
    Correspondent
    Rachel Easley

    Products

    Device Name Product Code
    Activated Whole Blood Clotting Time JBP

    Proprietary Names

    Actalyke XL Analyzer

    Establishment Types

    Manufacture Medical Device