Data / Medical devices / Instrument, Coagulation, Automated
Instrument, Coagulation, Automated (GKP): 13 FDA-registered makers in 4 countries
13 establishments in 4 countries are registered with the FDA to make Instrument, Coagulation, Automated (product code GKP, Class 2, 21 CFR 864.5400). 10 of them have a 510(k) clearance or PMA approval on file and 1 has a recall event. The FDA has issued 49 510(k) clearances under this code, the latest on August 16, 2024, and lists 11 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- GKP
- Device class
- 2
- Regulation
- 864.5400
- Medical specialty
- Hematology
Makers by country
| Country | Makers |
|---|---|
| United States | 6 |
| Japan | 4 |
| Germany | 2 |
| France | 1 |
Makers of Instrument, Coagulation, Automated
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Instrumentation Laboratory Co. | Bedford, MA, United States | Manufacturer | 4 | August 16, 2024 | 0 | 7 | 0 | api.fda.gov |
| Diagnostica Stago - Gennevilliers | Gennevilliers Hauts-de-Seine, France | Exporter to the US, Manufacturer | 2 | July 10, 1996 | 0 | 0 | 0 | api.fda.gov |
| Sysmex Corporation Techno Park | KOBE Hyogo, Japan | Specification developer | 2 | September 8, 2003 | 0 | 0 | 0 | api.fda.gov |
| Fisher Diagnostics | Middletown, VA, United States | Manufacturer | 1 | December 9, 2002 | 0 | 0 | 0 | api.fda.gov |
| Helena Laboratories, Corp. | Beaumont, TX, United States | Manufacturer | 1 | August 23, 1993 | 0 | 0 | 0 | api.fda.gov |
| Sysmex Corporation Kakogawa Factory | Kakogawa Hyogo, Japan | Manufacturer | 1 | June 27, 2002 | 0 | 0 | 0 | api.fda.gov |
| SYSMEX CORPORATION i-SQUARE | Kakogawa Hyogo, Japan | Manufacturer | 1 | June 27, 2002 | 0 | 0 | 0 | api.fda.gov |
| Sysmex America, Inc. | Buffalo Grove, IL, United States | Manufacturer | 1 | September 8, 2003 | 0 | 0 | 0 | api.fda.gov |
| Sysmex America, Inc. - Vernon Hills | Vernon Hills, IL, United States | Manufacturer | 1 | September 8, 2003 | 0 | 0 | 0 | api.fda.gov |
| Sysmex RA Co., LTD, Main Office | Shiojiri Nagano, Japan | Manufacturer | 1 | September 8, 2003 | 0 | 0 | 0 | api.fda.gov |
| Bemotec GMBH | Sonnenbühl Baden-Wurttemberg, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Siemens Healthcare Diagnostics Inc. | Tarrytown, NY, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Siemens Healthcare Diagnostics Products GmbH | MARBURG Hesse, Germany | Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated August 16, 2024. 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.