About This 510(k) Submission
K200249 is an FDA 510(k) clearance for the Sequential Culture Media (Fertilization Medium [without HSA/rHA, with HSA, with rHA], Cleavage Medium [without HSA/rHA, with HSA, with rHA], Blastocyst Medium [without HSA/rHA, with HSA, with rHA]), a Media, Reproductive (Class II — Special Controls, product code MQL), submitted by Kitazato Corporation (Fuji-Shi, JP). The FDA issued a Cleared decision on October 23, 2020, 263 days after receiving the submission on February 3, 2020. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.6180.