510(k) K120136

EMBRYOGEN by Origio A/S — Product Code MQL

K120136 is an FDA 510(k) premarket notification submitted by Origio A/S for the device "EMBRYOGEN". The FDA issued a decision of Substantially Equivalent on September 26, 2012. The device falls under product code MQL (Media, Reproductive), a Class II device regulated under 21 CFR 884.6180. Origio A/S has at least 10 other 510(k) clearances on record.