The following data is part of a premarket notification filed by Sysmex Corp. with the FDA for Sysmex Xe-2100, Automatated Hematology Analyzer.
| Device ID | K992875 |
| 510k Number | K992875 |
| Device Name: | SYSMEX XE-2100, AUTOMATATED HEMATOLOGY ANALYZER |
| Classification | Counter, Differential Cell |
| Applicant | SYSMEX CORP. ONE WILDLIFE WAY Long Grove, IL 60047 -9596 |
| Contact | Nina Gamperling |
| Correspondent | Nina Gamperling SYSMEX CORP. ONE 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 | 1999-08-26 |
| Decision Date | 1999-11-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04987562404087 | K992875 | 000 |