The following data is part of a premarket notification filed by Sysmex America, Inc. with the FDA for Sysmex Xn-l Automated Hematology Analyzer.
| Device ID | K160538 |
| 510k Number | K160538 |
| Device Name: | Sysmex XN-L Automated Hematology Analyzer |
| Classification | Counter, Differential Cell |
| Applicant | SYSMEX AMERICA, INC. 577 APTAKISIC ROAD Lincolnshire, IL 60069 |
| Contact | Sharita Brooks |
| Correspondent | Sharita Brooks SYSMEX AMERICA, INC. 577 APTAKISIC ROAD Lincolnshire, IL 60069 |
| Product Code | GKZ |
| CFR Regulation Number | 864.5220 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-02-26 |
| Decision Date | 2016-12-22 |
| Summary: | summary |