LEECO T3-QUANT DIAG. KIT

LEECO T3-QUANT DIAG. KIT is an FDA 510(k)-cleared medical device (K834348) manufactured by Leeco Diagnostics, Inc.. 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 February 20, 1984. Regulation: 8.