The following data is part of a premarket notification filed by Dynagen, Inc. with the FDA for Niccheck I.
| Device ID | K963733 |
| 510k Number | K963733 |
| Device Name: | NICCHECK I |
| Classification | Test System, Nicotine, Cotinine, Metabolites |
| Applicant | DYNAGEN, INC. 99 ERIE ST. Cambridge, MA 02139 |
| Contact | Peter J Mione |
| Correspondent | Peter J Mione DYNAGEN, INC. 99 ERIE ST. Cambridge, MA 02139 |
| Product Code | MRS |
| CFR Regulation Number | 862.3220 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-09-16 |
| Decision Date | 1996-12-13 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00860007588907 | K963733 | 000 |