510(k) K010183

GLOBAL BY <GENX> BLASTOCYST MEDIA by <Genx> Intl., Inc. — Product Code MQL

K010183 is an FDA 510(k) premarket notification submitted by <Genx> Intl., Inc. for the device "GLOBAL BY <GENX> BLASTOCYST MEDIA". The FDA issued a decision of Substantially Equivalent on May 2, 2001. 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 10 other 510(k) clearances on record.