CONNECTICUT DIAGNOSTICS, LTS. DIRECT

CONNECTICUT DIAGNOSTICS, LTS. DIRECT is an FDA 510(k)-cleared medical device (K792465) manufactured by Connecticut Diagnostics, Ltd.. 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 17, 1979. Regulation: 8.