ARCHITECT STAT High Sensitivity Troponin-I

ARCHITECT STAT High Sensitivity Troponin-I is an FDA 510(k)-cleared medical device (K191595) manufactured by Abbott Laboratories Diagnostics Division. 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 September 12, 2019. Regulation: 8.