Toa Medical Electronics CA-5000
FDA 510(k) K933886 · Toa Medical Electronics USA, Inc.
510(k) numberK933886
Submission
- Device name
- Toa Medical Electronics CA-5000
- Applicant
- Toa Medical Electronics USA, Inc.
Los Alamitos, CA, US - Received
- August 10, 1993
- Decision date
- January 27, 1994
- 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 |
|---|---|---|
| K936023 | Sysmex SE-9000 Automated Hematology AnalyzerGKZ · Traditional | 05/02/1994SE |
| K931149 | CA-1000 Automated Coagulation AnalyzerJPA · Traditional | 11/03/1993SE |
| K920544 | Sysmex Hematology System AccessoriesGKZ · Traditional | 04/29/1992SE |
| K914744 | Sysmex NE-1500, ModificationGKZ · Traditional | 12/30/1991SE |
| K912494 | Sysmex(Tm) R-3000 Automated Reticulocyte AnalyzerGKL · Traditional | 09/10/1991SE |
| K911173 | Sysmex F-310GKL · Traditional | 07/26/1991SE |
| K911172 | Sysmex F-610GKL · Traditional | 07/26/1991SE |
| K910849 | Sysmex F-810GKL · Traditional | 07/26/1991SE |
| K910745 | Hemoglobin ReagentGKR · Traditional | 07/11/1991SE |
| K894539 | Sysmex R-1000 Automated Reticulocyte AnalyzerGKL · Traditional | 09/26/1989SE |
Questions and answers
When was Toa Medical Electronics CA-5000 cleared by the FDA?
Toa Medical Electronics CA-5000 (K933886) received a 510(k) decision of Substantially Equivalent on January 27, 1994, 170 days after the submission was received.
What is the product code of K933886?
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.