BEUDAMED
    FDA Registration Active 🇺🇸 United States

    SIENCO, INC.

    Reg #: 1719400 · FEI: 1719400 · Expires 2026
    View on FDA
    Products
    2
    Proprietary Names
    15
    Establishment Types
    2
    Classifications
    2

    Registration Details

    Registration Name
    SIENCO, INC.
    Registration Number
    1719400
    FEI Number
    1719400
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    5721 Arapahoe Ave., Suite A1-A
    City
    Boulder
    State
    CO
    ZIP
    80303
    Country
    US

    Regulatory Submissions

    510(k) Number
    K002528

    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
    System, Multipurpose For In Vitro Coagulation Studies JPA

    Proprietary Names

    Signature Viewer Sonoclot Analyzer SonACT Kit kACT Kit Reference Plasma QC Kit NonActivated Kit Reference Viscosity QC Kit gbACT+ Kit Sonoclot® Analyzer Sonoclot® Viewer aiACT Kit SCP1 Sonoclot Coagulation & Platelet Function Analyzer SCP2 Sonoclot Coagulation & Platelet Function Analyzer SC1 Sonoclot Coagulation Analyzer SCP4 Sonoclot Coagulation & Platelet Function Analyzer

    Establishment Types

    Manufacture Medical Device Manufacture Device in the United States for Export Only