The following data is part of a premarket notification filed by Sysmex America, Inc. with the FDA for Sysmex Automated Hematology Analyzer, Xe-2100 Series (xe-2100, Xe-2100l).
| Device ID | K040073 |
| 510k Number | K040073 |
| Device Name: | SYSMEX AUTOMATED HEMATOLOGY ANALYZER, XE-2100 SERIES (XE-2100, XE-2100L) |
| 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 | 2004-01-14 |
| Decision Date | 2004-03-18 |
| Summary: | summary |