Sysmex CA-1000/SYSMEX CA-5000
FDA 510(k) K964946 · Sysmex Corp.
510(k) numberK964946
Submission
- Device name
- Sysmex CA-1000/SYSMEX CA-5000
- Applicant
- Sysmex Corp.
Long Grove, IL, US - Received
- December 10, 1996
- Decision date
- March 18, 1997
- 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
| 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 |
|---|---|---|
| K012372 | Sysmex UF-50LKM · Traditional | 09/28/2001SE |
| K992875 | Sysmex XE-2100, Automatated Hematology AnalyzerGKZ · Traditional | 11/09/1999SE |
| K981950 | Sysmex R-3500, Automated Reticculocyte Analyzer, Model R-3500GKL · Traditional | 11/03/1998SE |
| K981761 | Sysmex KX-21, Automated Hematology AnalyzerGKL · Traditional | 08/14/1998SE |
| K971736 | Sysmex Immature Reticulocyte Fraction (Irf) ParameterGKZ · Traditional | 08/26/1997SE |
| K964375 | Sysmex SE/RAM-1GKL · Traditional | 03/13/1997SE |
| K961054 | Sysmex UF-100LKM · Traditional | 10/28/1996SE |
| K950508 | Sysmex SF-3000FPK · Traditional | 11/03/1995SE |
| K945837 | Sysmex(Tm) F-820, 520GKZ · Traditional | 06/09/1995SE |
| K942097 | Toa Medical Electronics CA-5000JPA · Traditional | 03/24/1995SE |
Questions and answers
When was Sysmex CA-1000/SYSMEX CA-5000 cleared by the FDA?
Sysmex CA-1000/SYSMEX CA-5000 (K964946) received a 510(k) decision of Substantially Equivalent on March 18, 1997, 98 days after the submission was received.
What is the product code of K964946?
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.