The following data is part of a premarket notification filed by Abbott Laboratories with the FDA for Axsym Benzodiazepines.
| Device ID | K951286 |
| 510k Number | K951286 |
| Device Name: | AXSYM BENZODIAZEPINES |
| Classification | Enzyme Immunoassay, Benzodiazepine |
| Applicant | ABBOTT LABORATORIES ONE ABBOTT PARK RD. Abbott Park, IL 60064 -3500 |
| Contact | Doug Kentz |
| Correspondent | Doug Kentz ABBOTT LABORATORIES ONE ABBOTT PARK RD. Abbott Park, IL 60064 -3500 |
| Product Code | JXM |
| CFR Regulation Number | 862.3170 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-03-21 |
| Decision Date | 1995-05-16 |