K160541 is an FDA 510(k) clearance for the Automated Immunoassay System HISCL -800, HISCL TSH Assay Kit, HISCL TSH Calibrator, HISCL Immuno Multi Control. This device is classified as a Radioimmunoassay, Thyroid-stimulating Hormone (Class II - Special Controls, product code JLW).
Submitted by Sysmex America, Inc. (Lincolnshire, US). The FDA issued a Cleared decision on October 21, 2016, 238 days after receiving the submission on February 26, 2016.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1690.
| 510(k) Number | K160541 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 26, 2016 |
| Decision Date | October 21, 2016 |
| Days to Decision | 238 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | JLW — Radioimmunoassay, Thyroid-stimulating Hormone |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1690 |