Sienco Inc

FDA Filings

This page includes the latest FDA filings for Sienco Inc. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

• Registration Number: 1719400
• FEI Number: 1719400
• Name: SIENCO, INC.
• Owner & Operator: SIENCO, INC.
• Contact Address: 5721 Arapahoe Avenue Suite A1-A; Boulder CO 80303 US
• Official Correspondent:
  • Jennifer Aiken
  • x-303-4201148-x
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 5721 Arapahoe Ave. Suite A1-A; Boulder, CO 80303 US
• Establishment Type:
  • Manufacture Medical Device
  • Manufacture Device in the United States for Export Only

FDA Filings

Device Company	Device	Date
GUDID B558DP29510 SIENCO, INC.	Sonoclot® Coagulation & Platelet Function Analyzer	2023-07-06
GUDID B55890013181 SIENCO, INC.	Sonoclot® Reference Plasma Quality Control Kit 900-1318	2021-07-27
GUDID B55890013020 SIENCO, INC.	Sonoclot® Reference Viscosity Oil Quality Control Kit 900-1302	2021-07-27
GUDID B55880004420 SIENCO, INC.	Sonoclot® aiACT Kit 800-0442	2021-07-27
GUDID B55880004410 SIENCO, INC.	Sonoclot® aiACT Kit 800-0441	2021-07-27
GUDID B55880004320 SIENCO, INC.	Sonoclot® SonACT Kit 800-0432	2021-07-27
GUDID B55880004310 SIENCO, INC.	Sonoclot® SonACT Kit 800-0431	2021-07-27
GUDID B55880004260 SIENCO, INC.	Sonoclot® NonActivated Kit 800-0426	2021-07-27
GUDID B55880004250 SIENCO, INC.	Sonoclot® NonActivated Kit 800-0425	2021-07-27
GUDID B55880004010 SIENCO, INC.	Sonoclot® kACT Kit 800-0401	2021-07-27
GUDID B55880004001 SIENCO, INC.	Sonoclot® kACT Kit 800-0400	2021-07-27
GUDID B55880004120 SIENCO, INC.	Sonoclot® gbACT+ Kit 800-0412	2021-06-03
GUDID B55880004110 SIENCO, INC.	Sonoclot® gbACT+ Kit 800-0411	2021-06-03
JPA SIENCO, INC.	SCP4 Sonoclot Coagulation & Platelet Function Analyzer	2014-04-23
JPA SIENCO, INC.	SCP2 Sonoclot Coagulation & Platelet Function Analyzer	2014-04-23
JPA SIENCO, INC.	SCP1 Sonoclot Coagulation & Platelet Function Analyzer	2014-04-23
JPA SIENCO, INC.	SC1 Sonoclot Coagulation Analyzer	2014-04-23
PMN K984141 | JBP SIENCO, INC.	gbACT+ Kit	2007-12-04
PMN K952560 | JPA SIENCO, INC.	kACT Kit	2007-12-04
PMN K952560 | JPA SIENCO, INC.	Sonoclot Analyzer	2007-12-04
PMN K952560 | JPA SIENCO, INC.	SonACT Kit	2007-12-04
PMN K952560 | JPA SIENCO, INC.	Reference Viscosity QC Kit	2007-12-04
PMN K952560 | JPA SIENCO, INC.	Reference Plasma QC Kit	2007-12-04
PMN K952560 | JPA SIENCO, INC.	NonActivated Kit	2007-12-04
PMN K032952 | JBP SIENCO, INC.	aiACT Kit	2007-12-04
PMN K002528 | JBP SIENCO, INC.	Sonoclot Analyzer	2007-12-04
PMN K002528 | JBP SIENCO, INC.	Signature Viewer	2007-12-04
PMN K032952 SIENCO, INC.	AIACT KIT	2003-12-12
PMN K002528 SIENCO, INC.	SONOCLOT COAGULATION & PLATELET FUNCTION ANALYZER SYSTEM WITH SIGNATURE VIEWER OPTION	2000-08-31
PMN K984141 SIENCO, INC.	GBACT + KIT	1999-05-28
PMN K952560 SIENCO, INC.	SONOCLOT COAGULATION & PLATELET FUNCTION ANALYZER	1995-09-05

Related Finance Registrations

NCAGE Code	02FM8	SIENCO INC
NCAGE Code	07RV6	SIENCO INC.
CAGE Code	02FM8	SIENCO INC
CAGE Code	07RV6	SIENCO, INC.
DUNS	064039514	SIENCO, INC.