K160538 is an FDA 510(k) clearance for the Sysmex XN-L Automated Hematology Analyzer. This device is classified as a Counter, Differential Cell (Class II - Special Controls, product code GKZ).
Submitted by Sysmex America, Inc. (Lincolnshire, US). The FDA issued a Cleared decision on December 22, 2016, 300 days after receiving the submission on February 26, 2016.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.5220.
| 510(k) Number | K160538 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 26, 2016 |
| Decision Date | December 22, 2016 |
| Days to Decision | 300 days |
| Submission Type | Traditional |
| Review Panel | Hematology (HE) |
| Summary | Summary PDF |
| Product Code | GKZ — Counter, Differential Cell |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 864.5220 |