The following data is part of a premarket notification filed by Sysmex Corp. with the FDA for Sysmex Kx-21, Automated Hematology Analyzer.
| Device ID | K981761 |
| 510k Number | K981761 |
| Device Name: | SYSMEX KX-21, AUTOMATED HEMATOLOGY ANALYZER |
| Classification | Counter, Cell, Automated (particle Counter) |
| 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 | GKL |
| CFR Regulation Number | 864.5200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-05-19 |
| Decision Date | 1998-08-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04987562429219 | K981761 | 000 |