GJS — Test, Time, Prothrombin Class II
FDA product code GJS covers "Test, Time, Prothrombin", a Class II medical device regulated under 21 CFR 864.7750. Submissions are reviewed by the Hematology panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- GJS
- Device Class
- Class II
- Regulation Number
- 864.7750
- Submission Type
- Review Panel
- HE
- Medical Specialty
- Hematology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K253188 | roche diagnostics | CoaguChek XS Plus System | October 24, 2025 |
| K251564 | iline microsystems, s.l | microINR System | July 21, 2025 |
| K243543 | iline microsystems, s.l | microINR System | February 27, 2025 |
| K230802 | universal biosensors pty | Xprecia Prime Coagulation System | March 15, 2024 |
| K220282 | abbott laboratories | i-STAT PTplus Cartridge with the i-STAT 1 System | July 14, 2023 |
| K231711 | iline microsystems, s.l | microINR System | July 11, 2023 |
| K211485 | diagnostica stago | STA- NeoPTimal | December 23, 2022 |
| K212779 | coagusense | Coag-Sense Prothrombin (PT) / INR Monitoring System for Patient Self-Testing | October 5, 2022 |
| K213426 | instrumentation laboratory | HemosIL ReadiPlasTin | August 16, 2022 |
| K201185 | iline microsystems, s.l | microINR System | December 18, 2020 |
| K183255 | coagusense | Coag-Sense Prothrombin Time (PT) / INR Monitoring Device | February 21, 2019 |
| K180780 | iline microsystems, s.l | microINR System | January 25, 2019 |
| K180693 | roche diagnostics | CoaguChek XS Pro System | April 19, 2018 |
| K180684 | roche diagnostics | CoaguChek XS Plus System | April 19, 2018 |
| K170960 | roche diagnostics | CoaguChek Vantus System | December 25, 2017 |
| K151964 | siemens healthcare diagnostics | Xprecia Stride Coagulation System, Xprecia System PT Controls | September 30, 2016 |
| K132722 | instrumentation laboratory | HEMOSIL RECOMBIPLASTIN 2G (8 ML VIAL) | January 22, 2014 |
| K122584 | instrumentation laboratory | HEMOSIL READIPLAS TIN | March 24, 2013 |
| K110212 | alere san diego, inc (formally biosite incorporate | INRATIO2 PI/NR MONITORING SYSTEM; INRATIO PT/INR TEST STRIP | May 1, 2012 |
| K092987 | biosite incorporated | INRATIO/INRATIO2 TEST STRIPS | June 11, 2010 |