The following data is part of a premarket notification filed by Sysmex America, Inc. with the FDA for Sysmex Model Xe-2100dc Automated Hematology Analyzer.
Device ID | K051459 |
510k Number | K051459 |
Device Name: | SYSMEX MODEL XE-2100DC AUTOMATED HEMATOLOGY ANALYZER |
Classification | Counter, Differential Cell |
Applicant | SYSMEX AMERICA, INC. ONE NELSON C. WHITE PARKWAY Mundelein, IL 60060 |
Contact | Nina Gamperling |
Correspondent | Nina Gamperling 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 | 2005-06-02 |
Decision Date | 2005-09-23 |
Summary: | summary |