FDA device listing
XQ-Series (XQ-320) Automated Hematology Analyzer,XQ-Series (XQ-520) Automated Hematology Analyzer
FDA device listing 1385701676 · SYSMEX CORPORATION
Key facts
| Proprietary names | XQ-Series (XQ-320) Automated Hematology Analyzer,XQ-Series (XQ-520) Automated Hematology Analyzer |
|---|---|
| Owner/operator | SYSMEX CORPORATION |
| Owner/operator number | 9014170 |
| Premarket submissions | K230887 |
| Product codes | GKZ |
| Device names | GKZ - Counter, Differential Cell |
| Device class | Class II |
| Classification regulations (21 CFR) | 864.5220 |
| Review panels | Hematology |
| Registered establishments | Sysmex America, Inc., Sysmex America, Inc. - Vernon Hills, SYSMEX CORPORATION, SYSMEX CORPORATION KAKOGAWA FACTORY, SYSMEX CORPORATION TECHNO PARK |
| Establishment registrations | 9613959, 3002759288, 3009495621, 3009711478, 3010421384, 3020704087 |
| FEI numbers | 3002759288, 3002808301, 3009495621, 3009711478, 3010421384, 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 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