The following data is part of a premarket notification filed by Sysmex Corporation Of America with the FDA for Sysmex R-500.
Device ID | K001683 |
510k Number | K001683 |
Device Name: | SYSMEX R-500 |
Classification | Counter, Cell, Automated (particle Counter) |
Applicant | SYSMEX CORPORATION OF AMERICA ONE WILDLIFE WAY Long Grove, IL 60047 -9596 |
Contact | Nina Gamperling |
Correspondent | Nina Gamperling SYSMEX CORPORATION OF AMERICA 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 | 2000-06-01 |
Decision Date | 2000-08-21 |