K240247 is an FDA 510(k) clearance for the ?MoFi? Cell Culture Basal Medium, 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 review panel. Regulated under 21 CFR 876.5885.
| 510(k) Number | K240247 FDA.gov |
| FDA Decision | Cleared 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 |