Automated Immunoassay System HISCL -800, HISCL TSH Assay Kit, HISCL TSH Calibra…
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K160541 FDA 510(k)
- FDA Product Code
- JLW FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 862.1690 FDA 510(k)
- Regulation Number
- 862.1690 FDA 510(k)
- Advisory Committee
- Clinical Chemistry FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The HISCL-800 Automated Immunoassay System is a fully automated chemiluminescent immunoassay analyzer designed for the quantitative measurement of thyroid-stimulating hormone (TSH) and other immunoassay targets. It employs high-sensitivity chemiluminescent technology to detect and quantify biomarkers in serum or plasma samples, supporting clinical diagnostics in endocrinology and thyroid function testing.
The system is intended for use in clinical laboratories and is supplied as a complete immunoassay platform, including assay kits, calibrators, and multi-controls for quality assurance. Components are intended for single-use, with the analyzer itself designed for reusable operation under controlled laboratory conditions. The device complies with FDA 510(k) clearance and IVDR requirements, adhering to regulatory standards for in vitro diagnostic medical devices. Storage and handling follow manufacturer guidelines to maintain sterility and performance integrity.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (2 countries)
Regulatory Authorizations
IVDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | IVDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K160541 | Class II | Active |
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Manufacturer
- Manufacturer
- Sysmex America, Inc.
Sources (2)
- FDA 510(k) K160541 24 fields · synced Oct 6, 2026
- EUDAMED 1 fields · synced May 19, 2026