510(k) DEN000008
- Device
- DULBECCO'S MODIFIED EAGLE MEDIUM (DMEM)
- Applicant
- Life Technologies, Inc.
- 510(k) number
- DEN000008
- Product code
- NDS
- Decision
- Unknown (DENG)
- Decision date
- 2001-02-16
- Date received
- 2000-12-19
- Regulation
- 876.5885
- Classification name
- Media, Culture, Ex Vivo, Tissue And Cell
- Medical specialty
- Gastroenterology, Urology
- Review panel
- Gastroenterology, Urology
- Device class
- 2
- Clearance type
- Post-NSE
- Third party reviewed
- N
Applicant Contact#
- Contact
- JONATHAN S KAHAN, ESQ.
- Address
- 555 Thirteenth St. NW Washington DC US 20004 20004
FDA Registration Numbers#
- 3016633010
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code NDS#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K232543 | MSC SFM | Yocon Biology Technology Company | 2024-09-06 |
| K240247 | “MoFi” Cell Culture Basal Medium | Duogenic Stemcells Corporation | 2024-07-12 |
| K231804 | PRIME-XV FreezIS DMSO-Free MD | Fujifilm Irvine Scientific | 2023-11-09 |
| K201789 | CT-STOR | Energy Delivery Solutions | 2021-09-20 |
| K113566 | OPTMIZER CTS T-CELL EXPANSION SERUM FREE MEDIUM | Life Technologies, Inc. | 2012-06-21 |
| K103302 | STEMPRO MSC SFM | Life Technologies Corporation | 2011-02-18 |
| K100616 | KNOCKOUT SR MEDIUM, KNOCKOUT SR XENOFREE MEDIUM MODEL 10828, 12618 | Life Technologies Corporation | 2010-05-20 |
| K022086 | AIM-V (R) MEDIUM, MODEL 087-0112 | Invitrogen Corporation | 2002-12-23 |