IMMULITE TROPONIN I, MODEL LKTI1 AND LKT15

IMMULITE TROPONIN I, MODEL LKTI1 AND LKT15 is an FDA 510(k)-cleared medical device (K983972) manufactured by Diagnostic Products Corp.. 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 December 6, 1998. Regulation: 8.