K231804 is an FDA 510(k) clearance for the PRIME-XV FreezIS DMSO-Free MD, a Media, Culture, Ex Vivo, Tissue And Cell (Class II — Special Controls, product code NDS), submitted by Fujifilm Irvine Scientific (Santa Ana, US). The FDA issued a Cleared decision on November 9, 2023, 142 days after receiving the submission on June 20, 2023. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5885.
| 510(k) Number | K231804 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | June 20, 2023 |
| Decision Date | November 09, 2023 |
| Days to Decision | 142 days |
| Submission Type | Abbreviated |
| 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 |