510(k) K254261

Vitrification Freeze Kit and Thawing Kit (CS-IVF-FK; CS-IVF-TK) by CELL STORE (BEIJING) BIOTECHNOLOGY CO., LTD. — Product Code MQL

K254261 is an FDA 510(k) premarket notification submitted by CELL STORE (BEIJING) BIOTECHNOLOGY CO., LTD. for the device "Vitrification Freeze Kit and Thawing Kit (CS-IVF-FK; CS-IVF-TK)". The FDA issued a decision of Substantially Equivalent on August 28, 2026. The device falls under product code MQL (Media, Reproductive), a Class II device regulated under 21 CFR 884.6180.