510(k) K140207

RAPID-I KIT by Vitrolife Sweden AB — Product Code MQK

K140207 is an FDA 510(k) premarket notification submitted by Vitrolife Sweden AB for the device "RAPID-I KIT". The FDA issued a decision of Substantially Equivalent on December 18, 2014. The device falls under product code MQK (Labware, Assisted Reproduction), a Class II device regulated under 21 CFR 884.6160. Vitrolife Sweden AB has at least 10 other 510(k) clearances on record.