EDC/TITAN GELISO-DOT TOTAL LDH ISOENZYME PROCEDURE

EDC/TITAN GELISO-DOT TOTAL LDH ISOENZYME PROCEDURE is an FDA 510(k)-cleared medical device (K852391) manufactured by Helena Laboratories. 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 September 30, 1985. Regulation: 8.