NDS — Media, Culture, Ex Vivo, Tissue And Cell Class II
FDA product code NDS covers "Media, Culture, Ex Vivo, Tissue And Cell", a Class II medical device regulated under 21 CFR 876.5885. Submissions are reviewed by the Gastroenterology, Urology panel. At least 9 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- NDS
- Device Class
- Class II
- Regulation Number
- 876.5885
- Submission Type
- Review Panel
- GU
- Medical Specialty
- Gastroenterology, Urology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K232543 | yocon biology technology | MSC SFM | September 6, 2024 |
| K240247 | duogenic stemcells corporation | MoFi Cell Culture Basal Medium | July 12, 2024 |
| K231804 | fujifilm irvine scientific | PRIME-XV FreezIS DMSO-Free MD | November 9, 2023 |
| K201789 | energy delivery solutions | CT-STOR | September 20, 2021 |
| K113566 | life technologies | OPTMIZER CTS T-CELL EXPANSION SERUM FREE MEDIUM | June 21, 2012 |
| K103302 | life technologies corporation | STEMPRO MSC SFM | February 18, 2011 |
| K100616 | life technologies corporation | KNOCKOUT SR MEDIUM, KNOCKOUT SR XENOFREE MEDIUM MODEL 10828, 12618 | May 20, 2010 |
| K022086 | invitrogen corporation | AIM-V (R) MEDIUM, MODEL 087-0112 | December 23, 2002 |
| DEN000008 | life technologies | DULBECCO'S MODIFIED EAGLE MEDIUM (DMEM) | February 16, 2001 |