BEUDAMED
    FDA Registration Active 🇺🇸 United States

    gbACT+ Kit

    Reg #: 1719400 · FEI: 1719400 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    SIENCO, INC.
    Registration Number
    1719400
    FEI Number
    1719400
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    5721 Arapahoe Ave., Suite A1-A
    City
    Boulder
    State
    CO
    ZIP
    80303
    Country
    US

    Regulatory Submissions

    510(k) Number
    K984141

    Owner / Operator

    Firm Name
    SIENCO, INC.
    Operator Number
    1719400
    Address
    5721 Arapahoe Avenue, Suite A1-A
    City
    Boulder
    State
    CO
    Postal Code
    80303
    Country
    US
    Correspondent
    Jennifer Aiken

    Products

    Device Name Product Code
    Activated Whole Blood Clotting Time JBP

    Proprietary Names

    gbACT+ Kit

    Establishment Types

    Manufacture Medical Device