510(k) K200408

VitaVitro® Fertilization Medium, VitaVitro® Gamete Buffer Medium, VitaVitro® Flushing Buffer Medium by Shenzhen Vitavitro Biotech Co., Ltd. — Product Code MQL

K200408 is an FDA 510(k) premarket notification submitted by Shenzhen Vitavitro Biotech Co., Ltd. for the device "VitaVitro® Fertilization Medium, VitaVitro® Gamete Buffer Medium, VitaVitro® Flushing Buffer Medium". The FDA issued a decision of Substantially Equivalent on October 16, 2020. The device falls under product code MQL (Media, Reproductive), a Class II device regulated under 21 CFR 884.6180. Shenzhen Vitavitro Biotech Co., Ltd. has at least 4 other 510(k) clearances on record.