K232543 is an FDA 510(k) clearance for the MSC SFM. This device is classified as 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 FDA review panel. Regulated under 21 CFR 876.5885.
| 510(k) Number | K232543 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (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 |