Data / Medical devices / France / Diagnostica Stago - Gennevilliers
Diagnostica Stago - Gennevilliers: FDA-registered device maker in Gennevilliers Hauts-de-Seine, France, 10 510(k) clearances
Diagnostica Stago - Gennevilliers is registered with the FDA (registration 8043723) in Gennevilliers Hauts-de-Seine, France. It lists 8 device types. The FDA files 10 510(k) clearances under its listings, the newest dated April 27, 2026. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 8043723
- FEI number
- 3001573851
- Address
- 125 avenue Louis Roche, Gennevilliers Hauts-de-Seine, France, 92230
- Owner or operator
- Diagnostica Stago (10023909)
- Roles
- Exporter to the US, Manufacturer
- First device listed
- December 20, 2007
- Registered through
- 2027
- Brand names listed
- Data manager, ST art, STA - Satellite Max, STA Compact Max, STA Compact Max + cap piercing, STA R Max, STA R Max + cap piercing, STA Satellite and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Assay, Heparin | KFF | 2 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Calculator/Data Processing Module, For Clinical Use | JQP | 1 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control | DAP | 2 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Instrument, Coagulation, Automated | GKP | 2 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| System, Fibrinogen Determination | KQJ | 2 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| System, Multipurpose For In Vitro Coagulation Studies | JPA | 2 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Test, Time, Partial Thromboplastin | GGW | 2 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Test, Time, Prothrombin | GJS | 2 | Exporter to the US, Manufacturer | 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 |
|---|---|---|---|---|---|---|
| April 27, 2026 | K253658 | STA Satellite Max® | JPA | Substantially Equivalent | Diagnostica Stago, Inc. | accessdata.fda.gov |
| August 7, 2015 | K151867 | STA R MAX | JPA | Substantially Equivalent | Diagnostica Stago S.A.S | accessdata.fda.gov |
| February 12, 2013 | K130090 | STA COMPACT MAX | JPA | Substantially Equivalent | Diagnostica Stago, Incorporated | accessdata.fda.gov |
| December 22, 2009 | K093167 | STA COMPACT AUTOMATED MULTI-PARAMETRIC ANALYZER | JPA | Substantially Equivalent | Diagnostica Stago, Inc. | accessdata.fda.gov |
| December 18, 2009 | K093001 | STA-R EVOLUTION EXPERT SERIES HEMOSTASIS SYSTEM AUTOMATED MULTI-PARAMETRIC ANALYZER | JPA | Substantially Equivalent | Diagnostica Stago, Incorporated | accessdata.fda.gov |
| December 12, 2008 | K082248 | STA SATELLITE AUTOMATED MULTI-PARAMETER ANALYZER | JPA | Substantially Equivalent | Diagnostica Stago, Inc. | accessdata.fda.gov |
| October 10, 2008 | K082675 | STA-R EVOLUTION AUTOMATED MULTI-PARAMETRIC ANALYZER | JPA | Substantially Equivalent | Diagnostica Stago, Inc. | accessdata.fda.gov |
| November 12, 1998 | K983460 | STAR AUTOMATED MULTI-PARAMETRIC ANALYZER | JPA | Substantially Equivalent | American Bioproducts Co. | accessdata.fda.gov |
| July 10, 1996 | K961579 | STA COMPACT AUTOMATED MULTI-PARAMETRIC ANALYZER | GKP | Substantially Equivalent | American Bioproducts Co. | accessdata.fda.gov |
| November 13, 1990 | K904297 | ST-4 COAGULATION INSTRUMENT | GKP | Substantially Equivalent | American Bioproducts Co. | accessdata.fda.gov |
Compare with other makers
- All makers of System, Multipurpose For In Vitro Coagulation Studies
- All makers of Calculator/Data Processing Module, For Clinical Use
- All makers of Instrument, Coagulation, Automated
- All makers of Assay, Heparin
- All makers of Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control
- All makers of Test, Time, Partial Thromboplastin
Updated April 27, 2026. 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.