K083002 is an FDA 510(k) clearance for the SYSMEX UF-500I 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. (Mundelein, US). The FDA issued a Cleared decision on February 3, 2009, 118 days after receiving the submission on October 8, 2008.
This device falls under the Pathology FDA review panel. Regulated under 21 CFR 864.5200.
| 510(k) Number | K083002 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 08, 2008 |
| Decision Date | February 03, 2009 |
| Days to Decision | 118 days |
| Submission Type | Special |
| Review Panel | Pathology (PA) |
| Summary | Summary PDF |
| Product Code | LKM — Counter, Urine Particle |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 864.5200 |