K240247 is an FDA 510(k) clearance for the “MoFi” Cell Culture Basal Medium. This device is classified as a Media, Culture, Ex Vivo, Tissue And Cell (Class II - Special Controls, product code NDS).
Submitted by Duogenic Stemcells Corporation (Taichung City, TW). The FDA issued a Cleared decision on July 12, 2024, 164 days after receiving the submission on January 30, 2024.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5885.
| 510(k) Number | K240247 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 30, 2024 |
| Decision Date | July 12, 2024 |
| Days to Decision | 164 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 |