The following data is part of a premarket notification filed by Sysmex America, Inc. with the FDA for Sysmex Xn-series.
| Device ID | K112605 |
| 510k Number | K112605 |
| Device Name: | SYSMEX XN-SERIES |
| Classification | Counter, Differential Cell |
| Applicant | SYSMEX AMERICA, INC. 577 Aptakisic Rd Lincolnshire, IL 60069 |
| Contact | Sharita Brooks |
| Correspondent | Sharita Brooks SYSMEX AMERICA, INC. 577 Aptakisic Rd 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 | 2011-09-07 |
| Decision Date | 2012-10-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04987562424221 | K112605 | 000 |
| 04987562424214 | K112605 | 000 |