TEG 6s Hemostasis System
FDA 510(k) K160502 · Haemonetics Corporation
510(k) numberK160502
Submission
- Device name
- TEG 6s Hemostasis System
- Applicant
- Haemonetics Corporation
Braintree, MA, US - Received
- February 23, 2016
- Decision date
- April 19, 2017
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- JPA – System, Multipurpose For In Vitro Coagulation Studies
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.5425
- Specialty
- Hematology
Other 510(k)s with product code JPA
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253658 | STA Satellite Max®JPA · Traditional | Diagnostica Stago, Inc. | 04/27/2026SE |
| K250965 | Automated Blood Coagulation Analyzer CN-Series (CN-6000)JPA · Traditional | Sysmex America, Inc. | 06/02/2025SE |
| K251024 | TEG 6s Hemostasis System Citrated: K, KH, RT, FF Assay CartridgeJPA · Special | Haemonetics | 04/30/2025SE |
| K243858 | TEG 6s Hemostasis System Citrated: K, KH, RT, FF Assay CartridgeJPA · Special | Haemonetics Corporation | 01/15/2025SE |
| K232018 | Citrated: K, KH, RTH, FFHJPA · Traditional | Haemonetics Corporation | 03/29/2024SE |
| K233790 | Acl Top 970 CLJPA · Special | Instrumentation Laboratory | 12/29/2023SE |
| K221359 | ACL TOP 970 CL, HemosIL CL Anti-Cardiolipin IgM, HemosIL CL Anti-ß2 Glycoprotein-I IgMJPA · Traditional | Instrumentation Laboratory CO | 09/29/2023SE |
| K212183 | STA R Max 3, STA Compact Max 3JPA · Traditional | Diagnostica Stago S.A.S | 06/07/2023SE |
| K201440 | ROTEM sigma Thromboelastometry SystemJPA · Traditional | Tem Innovations GmbH | 07/08/2022SE |
| K202101 | GEM Hemochron 100 System, GEM Hemochron 100 Activated Clotting Time Plus Test (ACT+)…JPA · Traditional | Accriva Diagnostics, Inc. | 12/29/2021SE |
More from Accriva Diagnostics, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K251024 | TEG 6s Hemostasis System Citrated: K, KH, RT, FF Assay CartridgeJPA · Special | 04/30/2025SE |
| K243858 | TEG 6s Hemostasis System Citrated: K, KH, RT, FF Assay CartridgeJPA · Special | 01/15/2025SE |
| K232018 | Citrated: K, KH, RTH, FFHJPA · Traditional | 03/29/2024SE |
| K221722 | Haemonetics Cell Saver Elite/Elite+ Autotransfusion System (CSE-E-US/CSE-EW-US)CAC · Traditional | 11/15/2022SE |
| K183160 | TEG 6s Hemostasis System, TEG 6s Citrated: K, RT, FF Assay CartridgeJPA · Traditional | 05/09/2019SE |
| K162423 | Haemonetics Cell Saver Elite/Elite+ Autotransfusion SystemCAC · Traditional | 01/03/2017SE |
| K160197 | Haemonetics Cell Saver Elite Autotransfusion SystemCAC · Traditional | 05/24/2016SE |
| K122262 | Orthopat Advance Perioperative Autotransfusion SystemCAC · Traditional | 10/25/2012SE |
| K120586 | Cell Saver EliteCAC · Traditional | 05/22/2012SE |
| K101907 | Haemonetics Cell Saver Elite Autotransfusion SystemCAC · Traditional | 12/03/2010SE |
Questions and answers
When was TEG 6s Hemostasis System cleared by the FDA?
TEG 6s Hemostasis System (K160502) received a 510(k) decision of Substantially Equivalent on April 19, 2017, 421 days after the submission was received.
What is the product code of K160502?
The FDA product code is JPA – System, Multipurpose For In Vitro Coagulation Studies, a Class II (moderate risk) device regulated under 21 CFR 864.5425.