FDA device listing
Automated Immunoassay System HISCL-800,HISCL Immuno Multi Control,HISCL TSH Assay Kit,HISCL TSH Calibrator
FDA device listing 1944308338 · SYSMEX CORPORATION
Key facts
| Proprietary names | Automated Immunoassay System HISCL-800,HISCL Immuno Multi Control,HISCL TSH Assay Kit,HISCL TSH Calibrator |
|---|---|
| Owner/operator | SYSMEX CORPORATION |
| Owner/operator number | 9014170 |
| Premarket submissions | K160541 |
| Product codes | JIT, JJE, JJY, JLW |
| Device names | JIT - Calibrator, Secondary, JJE - Analyzer, Chemistry (Photometric, Discrete), For Clinical Use, JJY - Multi-Analyte Controls, All Kinds (Assayed), JLW - Radioimmunoassay, Thyroid-Stimulating Hormone |
| Device class | Class I, Class II |
| Classification regulations (21 CFR) | 862.1150, 862.1660, 862.1690, 862.2160 |
| Review panels | Clinical Chemistry |
| Registered establishments | Sysmex America, Inc., SYSMEX CORPORATION, SYSMEX CORPORATION TECHNO PARK |
| Establishment registrations | 9613959, 3009711478, 3010421384 |
| FEI numbers | 3002808301, 3009711478, 3010421384 |
| Establishment operations | Complaint File Establishment, 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