FDA device listing
SP-10,SP-50
FDA device listing 1181515875 · SYSMEX CORPORATION
Key facts
| Proprietary names | SP-10,SP-50 |
|---|---|
| Owner/operator | SYSMEX CORPORATION |
| Owner/operator number | 9014170 |
| Product codes | KPA |
| Device names | KPA - Slide Stainer, Automated |
| Device class | Class I |
| Classification regulations (21 CFR) | 864.3800 |
| Review panels | Pathology |
| Registered establishments | Sysmex America, Inc., Sysmex America, Inc. - Vernon Hills, SYSMEX CORPORATION, SYSMEX CORPORATION i-SQUARE, SYSMEX CORPORATION TECHNO PARK, Sysmex RA Co., LTD, Main Office |
| Establishment registrations | 9613959, 3009495621, 3009711478, 3010188766, 3010421384, 3010960914, 3020704087 |
| FEI numbers | 3002808301, 3009495621, 3009711478, 3010188766, 3010421384, 3010960914, 3020704087 |
| Establishment operations | Complaint File Establishment, Foreign Exporter, Manufacturer, Specification Developer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- None listed 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