The following data is part of a premarket notification filed by Nymox Pharmaceutical Corporation with the FDA for Nicalert.
| 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 | 
| Mark Image Registration | Serial | Company Trademark Application Date | 
|---|---|
|  NICALERT  76134477  2709821 Live/Registered | SEREX, INC. 2000-09-25 |