The following data is part of a premarket notification filed by Sysmex Corporation Of America with the FDA for Hpc (hematopoietic Progenitor Cell) Parameter On The Imi Channel Of The Sysmex Se-9500 And Xe-2100, Automated Hematology.
| Device ID | K020496 |
| 510k Number | K020496 |
| Device Name: | HPC (HEMATOPOIETIC PROGENITOR CELL) PARAMETER ON THE IMI CHANNEL OF THE SYSMEX SE-9500 AND XE-2100, AUTOMATED HEMATOLOGY |
| Classification | Counter, Differential Cell |
| Applicant | SYSMEX CORPORATION OF AMERICA 6699 WILDLIFE WAY Long Grove, IL 60047 -9596 |
| Contact | Nina Gamperling |
| Correspondent | Nina 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 | 2002-02-14 |
| Decision Date | 2002-04-12 |
| Summary: | summary |