The following data is part of a premarket notification filed by Sysmex America, Inc. with the FDA for Sysmex Model Xt-4000i.
Device ID | K091313 |
510k Number | K091313 |
Device Name: | SYSMEX MODEL XT-4000I |
Classification | Counter, Differential Cell |
Applicant | SYSMEX AMERICA, INC. ONE NELSON C. WHITE PARKWAY Mundelein, IL 60060 |
Contact | Sharita Brooks |
Correspondent | Sharita Brooks SYSMEX AMERICA, INC. ONE NELSON C. WHITE PARKWAY Mundelein, IL 60060 |
Product Code | GKZ |
CFR Regulation Number | 864.5220 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2009-05-04 |
Decision Date | 2010-03-30 |
Summary: | summary |