510(k) K092667

GLOBAL DMSO BLASTOCYST VITRIFICATION KIT AND WARMING KIT by Genx Intl., Inc. — Product Code MQL

K092667 is an FDA 510(k) premarket notification submitted by Genx Intl., Inc. for the device "GLOBAL DMSO BLASTOCYST VITRIFICATION KIT AND WARMING KIT". The FDA issued a decision of Substantially Equivalent on June 3, 2010. The device falls under product code MQL (Media, Reproductive), a Class II device regulated under 21 CFR 884.6180. Genx Intl., Inc. has at least 7 other 510(k) clearances on record.