K053135 is an FDA 510(k) clearance for the SYSMEX UF-100I AUTOMATED URINE CELL 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 January 4, 2006, 57 days after receiving the submission on November 8, 2005.
This device falls under the Pathology FDA review panel. Regulated under 21 CFR 864.5200.
| 510(k) Number | K053135 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 08, 2005 |
| Decision Date | January 04, 2006 |
| Days to Decision | 57 days |
| Submission Type | Traditional |
| 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 |