GLOBAL DMSO BLASTOCYST VITRIFICATION KIT AND WARMING KIT

GLOBAL DMSO BLASTOCYST VITRIFICATION KIT AND WARMING KIT is an FDA 510(k)-cleared medical device (K092667) manufactured by Genx Intl., Inc.. 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 June 2, 2010. Regulation: 8.