K232543 is an FDA 510(k) clearance for the MSC SFM, a Media, Culture, Ex Vivo, Tissue And Cell (Class II — Special Controls, product code NDS), submitted by Yocon Biology Technology Company (Beijing, CN). The FDA issued a Cleared decision on September 6, 2024, 381 days after receiving the submission on August 22, 2023. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5885.
| 510(k) Number | K232543 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | August 22, 2023 |
| Decision Date | September 06, 2024 |
| Days to Decision | 381 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | NDS — Media, Culture, Ex Vivo, Tissue And Cell |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 876.5885 |