ALLEGRO(TM) HUMAN CHORIONIC GONADOTROPIN IM SYSTEM

ALLEGRO(TM) HUMAN CHORIONIC GONADOTROPIN IM SYSTEM is an FDA 510(k)-cleared medical device (K872390) manufactured by Nichols Institute Diagnostics. 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 1, 1987. Regulation: 8.