Data / Medical devices / Test, Thrombin Time
Test, Thrombin Time (GJA): 5 FDA-registered makers in 3 countries
5 establishments in 3 countries are registered with the FDA to make Test, Thrombin Time (product code GJA, Class 2, 21 CFR 864.7875). 5 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 20 510(k) clearances under this code, the latest on December 12, 2005, and lists 3 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- GJA
- Device class
- 2
- Regulation
- 864.7875
- Medical specialty
- Hematology
Makers by country
| Country | Makers |
|---|---|
| United States | 3 |
| Germany | 1 |
| France | 1 |
Makers of Test, Thrombin Time
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 |
|---|---|---|---|---|---|---|---|---|
| Siemens Healthcare Diagnostics Products GmbH | MARBURG Hesse, Germany | Manufacturer | 2 | May 19, 1997 | 0 | 0 | 0 | api.fda.gov |
| Diagnostica Stago - Taverny | Taverny Val-d'Oise, France | Exporter to the US, Manufacturer | 1 | December 28, 1988 | 0 | 0 | 0 | api.fda.gov |
| Helena Laboratories, Corp. | Beaumont, TX, United States | Manufacturer | 1 | May 1, 1992 | 0 | 0 | 0 | api.fda.gov |
| Instrumentation Laboratory Co. | Orangeburg, NY, United States | Manufacturer | 1 | September 3, 1986 | 0 | 0 | 0 | api.fda.gov |
| R2 Diagnostics, Inc. | South Bend, IN, United States | Manufacturer | 1 | December 12, 2005 | 0 | 0 | 0 | api.fda.gov |
Updated December 12, 2005. 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.