
Abbott Laboratories Diagnostics Division
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Alinity i STAT High Sensitivity Troponin-I is an FDA 510(k)-cleared medical device (K202525) 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 May 18, 2022. Regulation: 8.