LAS-R HUMAN C1 ESTERASE INHIBITOR TEST

LAS-R HUMAN C1 ESTERASE INHIBITOR TEST is an FDA 510(k)-cleared medical device (K780335) manufactured by Hyland Therapeutic Div., Travenol Laboratories. This device is classified under the Immunology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on March 21, 1978. Regulation: 8.