ELECSYS FT4 II ASSAY, ELECSYS FT4 II CALSET

ELECSYS FT4 II ASSAY, ELECSYS FT4 II CALSET is an FDA 510(k)-cleared medical device (K131244) 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 26, 2014. Regulation: 8.