JPA
- Product code
- JPA
- Device name
- System, Multipurpose For In Vitro Coagulation Studies
- Device class
- Class 2
- 21 CFR
- 21 CFR 864.5425
- Medical specialty
- Hematology
- Marketing pathway
- 510(K)
- Flag
- Third-party review eligible
- 510(k) clearances (last 3 years)
- 7
- Summaries archived here
- 7 (direct download)
- 510(k) clearances (all years, FDA)
- 181 (all years; only the last 3 years are listed here)
510(k) clearances, last 3 years (7)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K253658 | 2026-04-27 | Diagnostica Stago, Inc. | STA Satellite Max® | |
| K250965 | 2025-06-02 | Sysmex America, Inc. | Automated Blood Coagulation Analyzer CN-Series (CN-6… | |
| K251024 | 2025-04-30 | Haemonetics | TEG 6s Hemostasis System Citrated: K, KH, RT, FF Ass… | |
| K243858 | 2025-01-15 | Haemonetics Corporation | TEG 6s Hemostasis System Citrated: K, KH, RT, FF As… | |
| K232018 | 2024-03-29 | Haemonetics Corporation | Citrated: K, KH, RTH, FFH | |
| K233790 | 2023-12-29 | Instrumentation Laboratory | ACL TOP 970 CL | |
| K221359 | 2023-09-29 | Instrumentation Laboratory CO | ACL TOP 970 CL, HemosIL CL Anti-Cardiolipin IgM, Hem… |
Official FDA classification page: JPA
Classification and pathway per current FDA publications. Data from openFDA (CC0).