510(k) K160541

Automated Immunoassay System HISCL -800, HISCL TSH Assay Kit, HISCL TSH Calibrator, HISCL Immuno Multi Control by Sysmex America, Inc. — Product Code JLW

K160541 is an FDA 510(k) premarket notification submitted by Sysmex America, Inc. for the device "Automated Immunoassay System HISCL -800, HISCL TSH Assay Kit, HISCL TSH Calibrator, HISCL Immuno Multi Control". The FDA issued a decision of Substantially Equivalent on October 21, 2016. The device falls under product code JLW (Radioimmunoassay, Thyroid-Stimulating Hormone), a Class II device regulated under 21 CFR 862.1690. Sysmex America, Inc. has at least 10 other 510(k) clearances on record.