GJS — Test, Time, Prothrombin Class II
FDA Device Classification
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 |