The following data is part of a premarket notification filed by Abbott Laboratories with the FDA for Axsym Tricyclic Antidepressants.
| Device ID | K953761 |
| 510k Number | K953761 |
| Device Name: | AXSYM TRICYCLIC ANTIDEPRESSANTS |
| Classification | U.v. Spectrometry, Tricyclic Antidepressant Drugs |
| Applicant | ABBOTT LABORATORIES ONE ABBOTT PARK RD. D389, AP30 Abbott Park, IL 60064 |
| Contact | Doug Kentz |
| Correspondent | Doug Kentz ABBOTT LABORATORIES ONE ABBOTT PARK RD. D389, AP30 Abbott Park, IL 60064 |
| Product Code | LFH |
| CFR Regulation Number | 862.3910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-08-11 |
| Decision Date | 1995-11-22 |