The following data is part of a De Novo classification by Life Technologies, Inc. with the FDA for Dulbecco's Modified Eagle Medium (dmem).
| DeNovo ID | DEN000008 |
| Device Name: | DULBECCO'S MODIFIED EAGLE MEDIUM (DMEM) |
| Classification | Media, Culture, Ex Vivo, Tissue And Cell |
| Applicant | LIFE TECHNOLOGIES, INC. 555 Thirteenth Street, N.w. Washington, DC 20004 -1109 |
| Contact | Jonathan S Kahan, Esq. |
| Product Code | NDS |
| CFR Regulation Number | 876.5885 [🔎] |
| Decision | Granted (DENG) |
| 510(k) Premarket Notification | K001447 |
| Review Advisory Board | Gastroenterology/Urology |
| Classification Advisory | Gastroenterology/Urology |
| Type | Post-NSE |
| Date Received | 2000-12-19 |
| Decision Date | 2001-02-16 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30190302002107 | DEN000008 | 000 |
| 30190302001438 | DEN000008 | 000 |
| 10190302001441 | DEN000008 | 000 |
| 10190302001458 | DEN000008 | 000 |
| 30190302001490 | DEN000008 | 000 |
| 30190302001476 | DEN000008 | 000 |
| 10190302001489 | DEN000008 | 000 |
| 30190302002046 | DEN000008 | 000 |
| 30190302002091 | DEN000008 | 000 |
| 30190302002350 | DEN000008 | 000 |
| 10190302002363 | DEN000008 | 000 |
| 10190302002370 | DEN000008 | 000 |
| 30190302001223 | DEN000008 | 000 |