Automated Blood Coagulation Analyzer CN-Series (CN-6000)
FDA 510(k) K250965 · Sysmex America, Inc.
510(k) numberK250965
Submission
- Device name
- Automated Blood Coagulation Analyzer CN-Series (CN-6000)
- Applicant
- Sysmex America, Inc.
Lincolnshire, IL, US - Received
- March 31, 2025
- Decision date
- June 2, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 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
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|---|---|---|---|
| K253658 | STA Satellite Max®JPA · Traditional | Diagnostica Stago, Inc. | 04/27/2026SE |
| 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 |
| K193041 | Hemochron Signature EliteJPA · Special | Accriva Diagnostics, Inc. | 11/22/2019SE |
More from Accriva Diagnostics, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K253212 | XR-Series (XR-10, XR-20) Automated Hematology AnalyzersGKZ · Traditional | 05/27/2026SE |
| K251371 | Sysmex XR-Series (XR-20) Automated Hematology AnalyzerGKZ · Traditional | 06/25/2025SE |
| K250943 | Sysmex XR-Series (XR-10) Automated Hematology AnalyzerGKZ · Traditional | 06/25/2025SE |
| K230887 | Sysmex XQ-Series (XQ-320) Automated Hematology AnalyzerGKZ · Traditional | 12/21/2023SE |
| K210346 | Sysmex XW-100 Automated Hematology AnalyzerGKZ · Dual Track | 11/08/2022SE |
| K182389 | Sysmex XN-L Automated Hematology AnalyzerGKZ · Traditional | 01/25/2019SE |
| K182062 | Sysmex UD-10, Fully Automated Urine Particle Digital Imaging DeviceJOY · Traditional | 10/30/2018SE |
| K171883 | Sysmex UF-5000 Fully Automated Urine Particle AnalyzerLKM · Traditional | 04/23/2018SE |
| K172604 | XW-100 Automated Hematology Analyzer for CLIA Waived UseGKZ · Dual Track | 11/06/2017SE |
| K160538 | Sysmex XN-L Automated Hematology AnalyzerGKZ · Traditional | 12/22/2016SE |
Questions and answers
When was Automated Blood Coagulation Analyzer CN-Series (CN-6000) cleared by the FDA?
Automated Blood Coagulation Analyzer CN-Series (CN-6000) (K250965) received a 510(k) decision of Substantially Equivalent on June 2, 2025, 63 days after the submission was received.
What is the product code of K250965?
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.