NDS
- Product code
- NDS
- Device name
- Media, Culture, Ex Vivo, Tissue And Cell
- Device class
- Class 2
- 21 CFR
- 21 CFR 876.5885
- Medical specialty
- Gastroenterology, Urology
- Marketing pathway
- 510(K)
- 510(k) clearances (last 3 years)
- 3
- Summaries archived here
- 3 (direct download)
- 510(k) clearances (all years, FDA)
- 9 (all years; only the last 3 years are listed here)
510(k) clearances, last 3 years (3)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K232543 | 2024-09-06 | Yocon Biology Technology Company | MSC SFM | |
| K240247 | 2024-07-12 | Duogenic Stemcells Corporation | MoFi Cell Culture Basal Medium | |
| K231804 | 2023-11-09 | Fujifilm Irvine Scientific | PRIME-XV FreezIS DMSO-Free MD |
Official FDA classification page: NDS
Classification and pathway per current FDA publications. Data from openFDA (CC0).