FDA device listing
Automated Blood Coagulation Analyzer CN-3000,Automated Blood Coagulation Analyzer CN-6000
FDA device listing 1803774242 · SYSMEX CORPORATION
Key facts
| Proprietary names | Automated Blood Coagulation Analyzer CN-3000,Automated Blood Coagulation Analyzer CN-6000 |
|---|---|
| Owner/operator | SYSMEX CORPORATION |
| Owner/operator number | 9014170 |
| Premarket submissions | K250965 |
| Product codes | JPA |
| Device names | JPA - System, Multipurpose For In Vitro Coagulation Studies |
| Device class | Class II |
| Classification regulations (21 CFR) | 864.5425 |
| Review panels | Hematology |
| Registered establishments | Sysmex America, Inc., SYSMEX CORPORATION, SYSMEX CORPORATION i-SQUARE, SYSMEX CORPORATION TECHNO PARK |
| Establishment registrations | 9613959, 3009711478, 3010421384, 3010960914 |
| FEI numbers | 3002808301, 3009711478, 3010421384, 3010960914 |
| Establishment operations | Complaint File Establishment, Foreign Exporter, Manufacturer, Specification Developer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- 1–9 UDI devices (GUDID) under the same submission
- 1–9 Device listings citing the same submission
- Yes Premarket submission listed
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device listings
Establishments that make or process devices for the U.S. market must list each device with the FDA. A listing records the device's proprietary names, product codes and premarket submission, and every registered establishment that handles it.
Source: U.S. Food and Drug Administration (FDA), Establishment Registration and Device Listing database