The following data is part of a premarket notification filed by Utak Laboratories, Inc. with the FDA for Amoxapine 8-hydro-xyamoxapine.
| Device ID | K831734 |
| 510k Number | K831734 |
| Device Name: | AMOXAPINE 8-HYDRO-XYAMOXAPINE |
| Classification | Drug Mixture Control Materials |
| Applicant | UTAK LABORATORIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | DIF |
| CFR Regulation Number | 862.3280 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-05-31 |
| Decision Date | 1983-07-26 |