Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

8043723

FEI Number

3001573851

Entity Name

Diagnostica Stago - Gennevilliers

City/State/Country

Gennevilliers Hauts-de-Seine, FR

Establishment Address

125 avenue Louis Roche, Gennevilliers Hauts-de-Seine 92230, FR

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Diagnostica Stago (Owner Number: 10023909)

Owner / Operator Contact Address

3 allee Theresa, Asnieres sur Seine, FR-92 92600, FR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K093167

PMA Number

N/A

All Registered Proprietary Names

Data manager STA Compact Max + cap piercing STA Compact Max STA Satellite ST art STA-R Evolution STA R Max + cap piercing STA Compact Max STA Compact Max + cap piercing

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
JQP	Calculator/Data Processing Module, For Clinical Use	Clinical Chemistry	Class 1	862.2100	2013-07-08
GKP	Instrument, Coagulation, Automated	Hematology	Class 2	864.5400	2007-12-20
JPA	System, Multipurpose For In Vitro Coagulation Studies	Hematology	Class 2	864.5425	2009-12-17
GKP	Instrument, Coagulation, Automated	Hematology	Class 2	864.5400	2007-12-20
JPA	System, Multipurpose For In Vitro Coagulation Studies	Hematology	Class 2	864.5425	2008-11-18
JPA	System, Multipurpose For In Vitro Coagulation Studies	Hematology	Class 2	864.5425	2010-04-23

Official Correspondent

No official correspondent registered.

US Agent Details

Donald KRAFT Business: DIAGNOSTICA STAGO, INC Email: donald.kraft@us.stago.com Phone: (973) 6311200

Related Public Records

Same Entity

Diagnostica Stago

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
9710666	Diagnostica Stago - Taverny	Taverny Val-d'Oise, FR

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K781173	Instrumentation Laboratory CO	COMPUTER INTERFACE IL 814	1978-09-14
K961991	Instrumentation Laboratory CO	ACL 6000 SYSTEM (ACL 6000)	1996-09-04
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-0007-04	Misys Healthcare Systems	1	Calculator/Data Processing Module for Clinical Use
Z-0026-2025	Becton Dickinson & Co.	1	BD Synapsys Informatics Solution with software versions: 4.20, 4.30, 5.10, 5.20 and 5.30- IVD standalone laboratory software solution providing data management and workflow management functionality across locations where clinical diagnostic activities take place. Catalog Number: 444150
Z-0039-2008	Diagnostica Stago, Inc.	2	STA Compact and STA Compact CT, Haemostasis Analyzer, in vitro diagnostic.
Z-0135-2011	Instrumentation Laboratory Co.	2	ACL TOP (Base) PN 000280000 Bench top, fully automated, random access analyzer designed specifically for in vitro diagnostic clinical use in the hemostasis laboratory for coagulation and/or fibrinolysis testing in the assessment of thrombosis and/or hemostasis. The systems provide results for both direct hemostasis measurements and calculated parameters
Z-0136-2011	Instrumentation Laboratory Co.	2	ACL TOP 500 CTS PN 000280040 Bench top, fully automated, random access analyzer designed specifically for in vitro diagnostic clinical use in the hemostasis laboratory for coagulation and/or fibrinolysis testing in the assessment of thrombosis and/or hemostasis. The systems provide results for both direct hemostasis measurements and calculated parameters.

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3012436569	NATIONAL TECHNOLOGY FOR SOFTWARE	Cairo Al Qahirah, EG
3015426626	Aclarion, Inc.	Broomfield, CO, US
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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 8043723. Last updated year: 2026. Please use registration number 8043723 when referencing this establishment in official correspondence.