510(k) K993881

GENX CULTURE DISH by <Genx> Intl., Inc. — Product Code MQK

K993881 is an FDA 510(k) premarket notification submitted by <Genx> Intl., Inc. for the device "GENX CULTURE DISH". The FDA issued a decision of Substantially Equivalent on February 14, 2000. The device falls under product code MQK (Labware, Assisted Reproduction), a Class II device regulated under 21 CFR 884.6160. <Genx> Intl., Inc. has at least 10 other 510(k) clearances on record.