K231804 is an FDA 510(k) clearance for the PRIME-XV FreezIS DMSO-Free MD. This device is classified as 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 FDA review panel. Regulated under 21 CFR 876.5885.
| 510(k) Number | K231804 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (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 |