The following data is part of a premarket notification filed by Sysmex Corporation Of America with the FDA for Sysmex Xt-series, Model Xt-2000i And Xt-1800i.
| Device ID | K021241 |
| 510k Number | K021241 |
| Device Name: | SYSMEX XT-SERIES, MODEL XT-2000I AND XT-1800I |
| Classification | Counter, Differential Cell |
| Applicant | SYSMEX CORPORATION OF AMERICA 6699 WILDLIFE WAY Long Grove, IL 60047 -9596 |
| Contact | Nina M Gamperling' |
| Correspondent | Nina M Gamperling' SYSMEX CORPORATION OF AMERICA 6699 WILDLIFE WAY Long Grove, IL 60047 -9596 |
| Product Code | GKZ |
| CFR Regulation Number | 864.5220 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-04-19 |
| Decision Date | 2002-06-25 |
| Summary: | summary |