Sta-R Evolution Expert Series Hemostasis System Automated Multi-Parametric Analyzer
FDA 510(k) K093001 · Diagnostica Stago, Incorporated
510(k) numberK093001
Submission
- Device name
- Sta-R Evolution Expert Series Hemostasis System Automated Multi-Parametric Analyzer
- Applicant
- Diagnostica Stago, Incorporated
Parisppany, NJ, US - Received
- September 28, 2009
- Decision date
- December 18, 2009
- 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 |
|---|---|---|
| K253658 | STA Satellite Max®JPA · Traditional | 04/27/2026SE |
| K162227 | STA® - Liatest® D-DiDAP · Traditional | 12/10/2016SE |
| K141144 | Sta Liatest D-DiDAP · Traditional | 09/03/2014SE |
| K120014 | Sta- Coag Control (N+Abn) PlusGGN · Traditional | 03/14/2013SE |
| K130090 | Sta Compact MaxJPA · Special | 02/12/2013SE |
| K111822 | Sta(R) - Liquid Anti-Xa, Multi Hep Calibrator, Quality HNF / Ufh, Quality HBPM / LMWHKFF · Traditional | 10/26/2011SE |
| K092937 | Sta-Hybrid Hep CalibratorJIT · Traditional | 08/02/2010SE |
| K093167 | Sta Compact Automated Multi-Parametric AnalyzerJPA · Special | 12/22/2009SE |
| K092170 | Sta Liatest Free PSGGP · Special | 12/22/2009SE |
| K092113 | Sta - Free PS CalibratorJIX · Traditional | 11/13/2009SE |
Questions and answers
When was Sta-R Evolution Expert Series Hemostasis System Automated Multi-Parametric Analyzer cleared by the FDA?
Sta-R Evolution Expert Series Hemostasis System Automated Multi-Parametric Analyzer (K093001) received a 510(k) decision of Substantially Equivalent on December 18, 2009, 81 days after the submission was received.
What is the product code of K093001?
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.