FDA Product Code
FDA Product Code NDS — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Gastroenterology, Urology
- 21 CFR Citation
- 876.5885
510(k) Clearances — 9 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K232543 | MSC SFM | Yocon Biology Technology Company | 2024-09-06 | Traditional | PDF ↗ |
| K240247 | MoFi Cell Culture Basal Medium | Duogenic Stemcells Corporation | 2024-07-12 | Traditional | PDF ↗ |
| K231804 | PRIME-XV FreezIS DMSO-Free MD | Fujifilm Irvine Scientific | 2023-11-09 | Abbreviated | PDF ↗ |
| K201789 | CT-STOR | Energy Delivery Solutions | 2021-09-20 | Traditional | PDF ↗ |
| K113566 | OPTMIZER CTS T-CELL EXPANSION SERUM FREE MEDIUM | Life Technologies, Inc. | 2012-06-21 | Traditional | PDF ↗ |
| K103302 | STEMPRO MSC SFM | Life Technologies Corporation | 2011-02-18 | Traditional | PDF ↗ |
| K100616 | KNOCKOUT SR MEDIUM, KNOCKOUT SR XENOFREE MEDIUM MODEL 10828, 12618 | Life Technologies Corporation | 2010-05-20 | Traditional | PDF ↗ |
| K022086 | AIM-V (R) MEDIUM, MODEL 087-0112 | Invitrogen Corporation | 2002-12-23 | Traditional | PDF ↗ |
| DEN000008 | DULBECCO'S MODIFIED EAGLE MEDIUM (DMEM) | Life Technologies, Inc. | 2001-02-16 | Post-NSE | — |
Product code NDS · Class II · Gastroenterology, Urology. Data: openFDA.