The following data is part of a premarket notification filed by Sysmex Corporation Of America with the FDA for Sysmex Xt-series, Model Xt-2000i And Xt-1800i.
Device ID | K021241 |
510k Number | K021241 |
Device Name: | SYSMEX XT-SERIES, MODEL XT-2000I AND XT-1800I |
Classification | Counter, Differential Cell |
Applicant | SYSMEX CORPORATION OF AMERICA 6699 WILDLIFE WAY Long Grove, IL 60047 -9596 |
Contact | Nina M Gamperling' |
Correspondent | Nina M 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 | 2002-04-19 |
Decision Date | 2002-06-25 |
Summary: | summary |