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 |