K212426 is an FDA 510(k) clearance for the Dewin Reproductive Media (Dewin Fertilization Medium [with HSA and without HSA] and Dewin Cleavage Medium [with HSA and without HSA]). This device is classified as a Media, Reproductive (Class II - Special Controls, product code MQL).
Submitted by Donnevie Medical Technology (Shanghai) Co. , Ltd. (Shanghai, CN). The FDA issued a Cleared decision on June 16, 2022, 316 days after receiving the submission on August 4, 2021.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.6180.
| 510(k) Number | K212426 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 04, 2021 |
| Decision Date | June 16, 2022 |
| Days to Decision | 316 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 |