K091313 is an FDA 510(k) clearance for the SYSMEX MODEL XT-4000I. This device is classified as a Counter, Differential Cell (Class II - Special Controls, product code GKZ).
Submitted by Sysmex America, Inc. (Mundelein, US). The FDA issued a Cleared decision on March 30, 2010, 330 days after receiving the submission on May 4, 2009.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.5220.
| 510(k) Number | K091313 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 04, 2009 |
| Decision Date | March 30, 2010 |
| Days to Decision | 330 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 |