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]). This device is classified as 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 FDA review panel. Regulated under 21 CFR 884.6180.
| 510(k) Number | K200249 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 03, 2020 |
| Decision Date | October 23, 2020 |
| Days to Decision | 263 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | Summary PDF |
| Product Code | MQL - Media, Reproductive |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 884.6180 |