IMMULITE TURBO TROPONIN I, MODELS LSKTI1, LSKTI5

IMMULITE TURBO TROPONIN I, MODELS LSKTI1, LSKTI5 is an FDA 510(k)-cleared medical device (K991795) 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 June 8, 1999. Regulation: 8.