The following data is part of a premarket notification filed by Wien Laboratories, Inc. with the FDA for Doxepin Tri-cy Test Set.
| Device ID | K821652 |
| 510k Number | K821652 |
| Device Name: | DOXEPIN TRI-CY TEST SET |
| Classification | Radioimmunoassay, Tricyclic Antidepressant Drugs |
| Applicant | WIEN LABORATORIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | LFG |
| CFR Regulation Number | 862.3910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-06-03 |
| Decision Date | 1982-06-14 |