MEDIA FOR GAMETE PREPARATION AND EMBRYO CULTURE

MEDIA FOR GAMETE PREPARATION AND EMBRYO CULTURE is an FDA 510(k)-cleared medical device (K002836) manufactured by Sage Biopharma. This device is classified under the Obstetrics/Gynecology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on October 2, 2000. Regulation: 8.