JPA — System, Multipurpose For In Vitro Coagulation Studies Class II
FDA product code JPA covers "System, Multipurpose For In Vitro Coagulation Studies", a Class II medical device regulated under 21 CFR 864.5425. 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
- JPA
- Device Class
- Class II
- Regulation Number
- 864.5425
- Submission Type
- Review Panel
- HE
- Medical Specialty
- Hematology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K253658 | diagnostica stago | STA Satellite Max® | April 27, 2026 |
| K250965 | sysmex america | Automated Blood Coagulation Analyzer CN-Series (CN-6000) | June 2, 2025 |
| K251024 | haemonetics | TEG 6s Hemostasis System Citrated: K, KH, RT, FF Assay Cartridge | April 30, 2025 |
| K243858 | haemonetics corporation | TEG 6s Hemostasis System Citrated: K, KH, RT, FF Assay Cartridge | January 15, 2025 |
| K232018 | haemonetics corporation | Citrated: K, KH, RTH, FFH | March 29, 2024 |
| K233790 | instrumentation laboratory | ACL TOP 970 CL | December 29, 2023 |
| K221359 | instrumentation laboratory | ACL TOP 970 CL, HemosIL CL Anti-Cardiolipin IgM, HemosIL CL Anti-ß2 Glycoprotein | September 29, 2023 |
| K212183 | diagnostica stago | STA R Max 3, STA Compact Max 3 | June 7, 2023 |
| K201440 | tem innovations | ROTEM sigma Thromboelastometry System | July 8, 2022 |
| K202101 | accriva diagnostics | GEM Hemochron 100 System, GEM Hemochron 100 Activated Clotting Time Plus Test (A | December 29, 2021 |
| K193041 | accriva diagnostics | Hemochron Signature Elite | November 22, 2019 |
| K183390 | diagnostic grifols | QNext and DG-PT | August 21, 2019 |
| K183160 | haemonetics corporation | TEG 6s Hemostasis System, TEG 6s Citrated: K, RT, FF Assay Cartridge | May 9, 2019 |
| K173202 | sekisui medical co | CP3000 Coagulation analyzer, Coagpia AT Reagent, Coagpia Calibrator, Coagpia Con | May 9, 2018 |
| K172286 | siemens healthcare diagnostic products | Automated Blood Coagulation Analyzer CS-2500 | December 18, 2017 |
| K172333 | siemens healthcare diagnostics products | Sysmex CS-5100 | October 31, 2017 |
| K160502 | haemonetics corporation | TEG 6s Hemostasis System | April 19, 2017 |
| K170314 | instrumentation laboratory | ACL AcuStar | March 3, 2017 |
| K162688 | siemens healthcare diagnostics products | Sysmex CS-2100i | December 26, 2016 |
| K162420 | siemens healthcare diagnostics products | Sysmex Automated Blood Coagulation Analyzer CS-5100 | December 12, 2016 |