SYSMEX XN-SERIES
FDA 510(k) clearance K112605 · decided 2012-10-19
Clearance details
- K-number
- K112605
- Device name
- SYSMEX XN-SERIES
- Applicant
- Sysmex America, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2011-09-07
- Decision date
- 2012-10-19
- Days to decision
- 408 days
- Clearance type
- Traditional
- Product code
- GKZ
- Device class
- 2
- Regulation number
- 864.5220
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- Lincolnshire, IL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Sysmex, Automated Hematology Analyzer XN Series, Sysmex Corporation, 1-5-1 Wakinohama-Kaig recall (Z-2034-2017) | Sysmex America Inc | 2017-04-14 |
| The XN-Series modules (XN-10, XN-20) are quantitative multi-parameter automated hematology recall (Z-1945-2016) | Sysmex Corporation | 2016-06-10 |