GJS
- Product code
- GJS
- Device name
- Test, Time, Prothrombin
- Device class
- Class 2
- 21 CFR
- 21 CFR 864.7750
- Medical specialty
- Hematology
- Marketing pathway
- 510(K)
- 510(k) clearances (last 3 years)
- 4
- Summaries archived here
- 4 (direct download)
- 510(k) clearances (all years, FDA)
- 127 (all years; only the last 3 years are listed here)
510(k) clearances, last 3 years (4)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K253188 | 2025-10-24 | Roche Diagnostics | CoaguChek XS Plus System | |
| K251564 | 2025-07-21 | Iline Microsystems, S.L. | microINR System | |
| K243543 | 2025-02-27 | Iline Microsystems, S.L. | microINR System | |
| K230802 | 2024-03-15 | Universal Biosensors Pty, Ltd. | Xprecia Prime Coagulation System |
Official FDA classification page: GJS
Classification and pathway per current FDA publications. Data from openFDA (CC0).