The following data is part of a premarket notification filed by Abbott Laboratories with the FDA for Abbott Axsym Ii System.
| Device ID | K950915 |
| 510k Number | K950915 |
| Device Name: | ABBOTT AXSYM II SYSTEM |
| Classification | Analyzer, Chemistry (photometric, Discrete), For Clinical Use |
| Applicant | ABBOTT LABORATORIES 200 ABBOTT PARK RD. Abbott Park, IL 60064 |
| Contact | Kathy Zeng |
| Correspondent | Kathy Zeng ABBOTT LABORATORIES 200 ABBOTT PARK RD. Abbott Park, IL 60064 |
| Product Code | JJE |
| CFR Regulation Number | 862.2160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-03-01 |
| Decision Date | 1995-05-16 |