510(k) K213869

EmbryoSlide+ ic8 dish by Vitrolife A/S — Product Code MQK

K213869 is an FDA 510(k) premarket notification submitted by Vitrolife A/S for the device "EmbryoSlide+ ic8 dish". The FDA issued a decision of Substantially Equivalent on March 11, 2022. The device falls under product code MQK (Labware, Assisted Reproduction), a Class II device regulated under 21 CFR 884.6160. Vitrolife A/S has at least 8 other 510(k) clearances on record.