Data / Medical devices / United States / Sienco, Inc.
Sienco, Inc.: FDA-registered device maker in Boulder, CO, United States, 5 510(k) clearances
Sienco, Inc. is registered with the FDA (registration 1719400) in Boulder, CO, United States. It lists 2 device types. The FDA files 5 510(k) clearances under its listings, the newest dated January 4, 2023. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 1719400
- Address
- 5721 Arapahoe Ave. Suite A1-A, Boulder, CO, United States, 80303
- Owner or operator
- SIENCO, INC. (1719400)
- Roles
- Manufacturer, Manufacturer for export
- First device listed
- December 4, 2007
- Registered through
- 2026
- Brand names listed
- NonActivated Kit, Reference Plasma QC Kit, Reference Viscosity QC Kit, SC1 Sonoclot Coagulation Analyzer, SCP1 Sonoclot Coagulation & Platelet Function Analyzer, SCP2 Sonoclot Coagulation & Platelet Function Analyzer, SCP4 Sonoclot Coagulation & Platelet Function Analyzer, Signature Viewer and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Activated Whole Blood Clotting Time | JBP | 2 | Manufacturer | accessdata.fda.gov |
| System, Multipurpose For In Vitro Coagulation Studies | JPA | 2 | Manufacturer, Manufacturer for export | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| January 4, 2023 | K223635 | Sonoclot Coagulation & Platelet Function Analyzer System with Sonoclot Viewer | JBP | Substantially Equivalent | Sienco, Inc. | accessdata.fda.gov |
| December 12, 2003 | K032952 | AIACT KIT | JBP | Substantially Equivalent | Sienco, Inc. | accessdata.fda.gov |
| August 31, 2000 | K002528 | SONOCLOT COAGULATION & PLATELET FUNCTION ANALYZER SYSTEM WITH SIGNATURE VIEWER OPTION | JBP | Substantially Equivalent | Sienco, Inc. | accessdata.fda.gov |
| May 28, 1999 | K984141 | GBACT + KIT | JBP | Substantially Equivalent | Sienco, Inc. | accessdata.fda.gov |
| September 5, 1995 | K952560 | SONOCLOT COAGULATION & PLATELET FUNCTION ANALYZER | JPA | Substantially Equivalent | Sienco, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Activated Whole Blood Clotting Time
- All makers of System, Multipurpose For In Vitro Coagulation Studies
Updated January 4, 2023. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.