510(k) K160541 ยท JLW Radioimmunoassay, Thyroid-Stimulating Hormone
Automated Immunoassay System HISCL -800, HISCL TSH Assay Kit, HISCL TSH Calibrator, HISCL Immuno Multi Control
| Applicant | Sysmex America, Inc., Lincolnshire IL, US |
| Decision | Substantially Equivalent, Oct 21, 2016 |
| Received | Feb 26, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K160541
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.