Elecsys TSH assay, cobas e 801 Immunoassay analyzer

Elecsys TSH assay, cobas e 801 Immunoassay analyzer is an FDA 510(k)-cleared medical device (K162606) manufactured by Roche Diagnostics. 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 January 22, 2017. Regulation: 8.