The following data is part of a premarket notification filed by Sysmex America, Inc. with the FDA for Automated Immunoassay System Hiscl -800, Hiscl Tsh Assay Kit, Hiscl Tsh Calibrator, Hiscl Immuno Multi Control.
| Device ID | K160541 |
| 510k Number | K160541 |
| Device Name: | Automated Immunoassay System HISCL -800, HISCL TSH Assay Kit, HISCL TSH Calibrator, HISCL Immuno Multi Control |
| Classification | Radioimmunoassay, Thyroid-stimulating Hormone |
| Applicant | SYSMEX AMERICA, INC. 577 Aptakisic Road Lincolnshire, IL 60069 |
| Contact | Michelle Parker |
| Correspondent | Michelle Parker SYSMEX AMERICA, INC. 577 Aptakisic Road Lincolnshire, IL 60069 |
| Product Code | JLW |
| Subsequent Product Code | JIT |
| Subsequent Product Code | JJE |
| Subsequent Product Code | JJY |
| CFR Regulation Number | 862.1690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-02-26 |
| Decision Date | 2016-10-21 |
| Summary: | summary |