510(k) K231370

Dewin Blastocyst Medium (with HSA and without HSA) by Donnevie Medical Technology (Shanghai) Co. , Ltd. — Product Code MQL

K231370 is an FDA 510(k) premarket notification submitted by Donnevie Medical Technology (Shanghai) Co. , Ltd. for the device "Dewin Blastocyst Medium (with HSA and without HSA)". The FDA issued a decision of Substantially Equivalent on August 4, 2023. The device falls under product code MQL (Media, Reproductive), a Class II device regulated under 21 CFR 884.6180. Donnevie Medical Technology (Shanghai) Co. , Ltd. has at least 3 other 510(k) clearances on record.