The following data is part of a premarket notification filed by Abbott Diagnostics with the FDA for Spectrophotometer #390.
| Device ID | K832206 |
| 510k Number | K832206 |
| Device Name: | SPECTROPHOTOMETER #390 |
| Classification | Colorimeter, Photometer, Spectrophotometer For Clinical Use |
| Applicant | ABBOTT DIAGNOSTICS 850 MAUDE AVE. Mountain View, CA 94043 |
| Product Code | JJQ |
| CFR Regulation Number | 862.2300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-07-07 |
| Decision Date | 1983-08-24 |