The following data is part of a premarket notification filed by Sysmex Corporation Of America with the FDA for Sysmex R-500.
| Device ID | K001683 |
| 510k Number | K001683 |
| Device Name: | SYSMEX R-500 |
| Classification | Counter, Cell, Automated (particle Counter) |
| Applicant | SYSMEX CORPORATION OF AMERICA ONE WILDLIFE WAY Long Grove, IL 60047 -9596 |
| Contact | Nina Gamperling |
| Correspondent | Nina Gamperling SYSMEX CORPORATION OF AMERICA ONE WILDLIFE WAY Long Grove, IL 60047 -9596 |
| Product Code | GKL |
| CFR Regulation Number | 864.5200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-06-01 |
| Decision Date | 2000-08-21 |