The following data is part of a premarket notification filed by Abbott Diagnostics with the FDA for Cell-dyn 400 Hemotology Analyzer.
| Device ID | K831368 |
| 510k Number | K831368 |
| Device Name: | CELL-DYN 400 HEMOTOLOGY ANALYZER |
| Classification | Counter, Cell, Automated (particle Counter) |
| Applicant | ABBOTT DIAGNOSTICS 850 MAUDE AVE. Mountain View, CA 94043 |
| Product Code | GKL |
| CFR Regulation Number | 864.5200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-04-26 |
| Decision Date | 1983-07-18 |