510(k) K092963

GLOBAL BLASTOCYST VITRIFICATION KIT & VITRIFICATION THAWING KIT - BASED ON S3 by Genx Intl., Inc. — Product Code MQL

K092963 is an FDA 510(k) premarket notification submitted by Genx Intl., Inc. for the device "GLOBAL BLASTOCYST VITRIFICATION KIT & VITRIFICATION THAWING KIT - BASED ON S3". The FDA issued a decision of Substantially Equivalent on January 14, 2011. 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.