Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1719400

FEI Number

1719400

Entity Name

SIENCO, INC.

City/State/Country

Boulder, CO, US

Establishment Address

5721 Arapahoe Ave., Suite A1-A, Boulder, CO 80303, US

Establishment Type(s)

Manufacture Device in the United States for Export Only

Owner / Operator

SIENCO, INC. (Owner Number: 1719400)

Owner / Operator Contact Address

5721 Arapahoe Avenue, Suite A1-A, Boulder, CO 80303, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Signature Viewer Sonoclot Analyzer 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

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
JBP	Activated Whole Blood Clotting Time	Hematology	Class 2	864.7140	2007-12-04
JPA	System, Multipurpose For In Vitro Coagulation Studies	Hematology	Class 2	864.5425	2007-12-04
JBP	Activated Whole Blood Clotting Time	Hematology	Class 2	864.7140	2007-12-04
JBP	Activated Whole Blood Clotting Time	Hematology	Class 2	864.7140	2023-06-21
JPA	System, Multipurpose For In Vitro Coagulation Studies	Hematology	Class 2	864.5425	2023-06-21
JBP	Activated Whole Blood Clotting Time	Hematology	Class 2	864.7140	2007-12-04
JPA	System, Multipurpose For In Vitro Coagulation Studies	Hematology	Class 2	864.5425	2014-04-23

Official Correspondent

Jennifer Aiken

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

SIENCO, INC.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K924453	Organon Teknika Corp.	MULTI-CHANNEL DISCRETE ANALYZER (MDA-180)	1992-12-18

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0032-06	BIOMERIEUX, INC.	2	VeriCal Calibrator Set
Z-0042-05	Dade Behring Inc. Rte 896, Glasgow Business Community	2	DispoSystem for BCT System.Model number OVFR03. Multipurpose System for in vitro coagulation studies.
Z-0043-05	bioMerieux	2	The MDA system with MDA Antithrombin III MDA Heparin
Z-0736-04	Instrumentation Laboratory Co.	2	ACL Futura Instrument Analyzer
Z-0737-04	Instrumentation Laboratory Co.	2	ACL Advance Instrument Analyzer

Similar Registrations

Registration Number	Establishment Name	Location
3019849102	Haemonetics Corporation	Clinton, PA, US
1644474	HELENA LABORATORIES, CORP.	BEAUMONT, TX, US
3005643513	ABBOTT POINT OF CARE CANADA LIMITED	Ottawa Ontario, CA
1718389	MEDTRONIC PERFUSION SYSTEMS	PARKER, CO, US
1217183	INSTRUMENTATION LABORATORY CO.	Bedford, MA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1719400. Last updated year: 2026. Please use registration number 1719400 when referencing this establishment in official correspondence.