The following data is part of a premarket notification filed by Sysmex America, Inc. with the FDA for Sysmex Uf-100i Automated Urine Cell Analyzer.
| Device ID | K053135 |
| 510k Number | K053135 |
| Device Name: | SYSMEX UF-100I AUTOMATED URINE CELL ANALYZER |
| Classification | Counter, Urine Particle |
| Applicant | SYSMEX AMERICA, INC. ONE NELSON C. WHITE PARKWAY Mundelein, IL 60060 |
| Contact | Nina Gamperling |
| Correspondent | Nina Gamperling SYSMEX AMERICA, INC. ONE NELSON C. WHITE PARKWAY Mundelein, IL 60060 |
| Product Code | LKM |
| CFR Regulation Number | 864.5200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-11-08 |
| Decision Date | 2006-01-04 |
| Summary: | summary |