K171883 is an FDA 510(k) clearance for the Sysmex UF-5000 Fully Automated Urine Particle Analyzer. This device is classified as a Counter, Urine Particle (Class II - Special Controls, product code LKM).
Submitted by Sysmex America, Inc. (Lincolnshire, US). The FDA issued a Cleared decision on April 23, 2018, 304 days after receiving the submission on June 23, 2017.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.5200.
| 510(k) Number | K171883 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 23, 2017 |
| Decision Date | April 23, 2018 |
| Days to Decision | 304 days |
| Submission Type | Traditional |
| Review Panel | Hematology (HE) |
| Summary | Summary PDF |
| Product Code | LKM — Counter, Urine Particle |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 864.5200 |