510(k) K160864

Cryotop Vitrification Kit and Cryotop Thawing Kit by Kitazato Biopharma Co., Ltd. — Product Code MQL

K160864 is an FDA 510(k) premarket notification submitted by Kitazato Biopharma Co., Ltd. for the device "Cryotop Vitrification Kit and Cryotop Thawing Kit". The FDA issued a decision of Substantially Equivalent on Oct 7, 2016. The device falls under product code MQL (Media, Reproductive), a Class II device regulated under 21 CFR 884.6180. Kitazato Biopharma Co., Ltd. has 5 other 510(k) clearances on record.