
Sysmex America, Inc.
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Automated Immunoassay System HISCL -800, HISCL TSH Assay Kit, HISCL TSH Calibrator, HISCL Immuno Multi Control is an FDA 510(k)-cleared medical device (K160541) manufactured by Sysmex America, Inc.. This device is classified under the Clinical Chemistry specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on October 20, 2016. Regulation: 8.