SYDNEY IVF EMBRYO BIOPSY MEDIUM

SYDNEY IVF EMBRYO BIOPSY MEDIUM is an FDA 510(k)-cleared medical device (K023850) manufactured by Cook Ob/Gyn. 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 January 21, 2003. Regulation: 8.