The following data is part of a premarket notification filed by Sysmex Corp. with the FDA for Sysmex R-3500, Automated Reticculocyte Analyzer, Model R-3500.
| Device ID | K981950 |
| 510k Number | K981950 |
| Device Name: | SYSMEX R-3500, AUTOMATED RETICCULOCYTE ANALYZER, MODEL R-3500 |
| Classification | Counter, Cell, Automated (particle Counter) |
| Applicant | SYSMEX CORP. ONE WILDLIFE WAY Long Grove, IL 60047 -9596 |
| Contact | Catherine M Trester |
| Correspondent | Catherine M Trester SYSMEX CORP. 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 | 1998-06-03 |
| Decision Date | 1998-11-03 |
| Summary: | summary |