NICALERT
Test System, Nicotine, Cotinine, Metabolites
NYMOX PHARMACEUTICAL CORPORATION
The following data is part of a premarket notification filed by Nymox Pharmaceutical Corporation with the FDA for Nicalert.
Pre-market Notification Details
| Device ID | K021688 |
| 510k Number | K021688 |
| Device Name: | NICALERT |
| Classification | Test System, Nicotine, Cotinine, Metabolites |
| Applicant | NYMOX PHARMACEUTICAL CORPORATION 230 WEST PASSAIC ST. Maywood, NJ 07607 |
| Contact | Michael Munzar |
| Correspondent | Michael Munzar NYMOX PHARMACEUTICAL CORPORATION 230 WEST PASSAIC ST. Maywood, NJ 07607 |
| Product Code | MRS |
| CFR Regulation Number | 862.3220 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-05-22 |
| Decision Date | 2002-10-18 |
Trademark Results [NICALERT]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 NICALERT 76134477 2709821 Live/Registered |
SEREX, INC. 2000-09-25 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.