DULBECCO'S MODIFIED EAGLE MEDIUM (DMEM)
FDA 510(k) clearance DEN000008 · decided 2001-02-16
Clearance details
- K-number
- DEN000008
- Device name
- DULBECCO'S MODIFIED EAGLE MEDIUM (DMEM)
- Applicant
- Life Technologies, Inc.
- Decision
- Unknown
- Date received
- 2000-12-19
- Decision date
- 2001-02-16
- Days to decision
- 59 days
- Clearance type
- Post-NSE
- Product code
- NDS
- Device class
- 2
- Regulation number
- 876.5885
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Washington, DC, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Life Technologies
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| MSC SFM (K232543) | Yocon Biology Technology Company | 2024-09-06 |
| “MoFi” Cell Culture Basal Medium (K240247) | Duogenic Stemcells Corporation | 2024-07-12 |
| PRIME-XV FreezIS DMSO-Free MD (K231804) | Fujifilm Irvine Scientific | 2023-11-09 |
| CT-STOR (K201789) | Energy Delivery Solutions | 2021-09-20 |
| OPTMIZER CTS T-CELL EXPANSION SERUM FREE MEDIUM (K113566) | Life Technologies, Inc. | 2012-06-21 |
| STEMPRO MSC SFM (K103302) | Life Technologies Corporation | 2011-02-18 |
| KNOCKOUT SR MEDIUM, KNOCKOUT SR XENOFREE MEDIUM MODEL 10828, 12618 (K100616) | Life Technologies Corporation | 2010-05-20 |
| AIM-V (R) MEDIUM, MODEL 087-0112 (K022086) | Invitrogen Corporation | 2002-12-23 |
Recalls involving this device
No recalls on record reference this clearance.