The following data is part of a premarket notification filed by Sysmex Corp. with the FDA for Sysmex Uf-50.
| Device ID | K012372 |
| 510k Number | K012372 |
| Device Name: | SYSMEX UF-50 |
| Classification | Counter, Urine Particle |
| Applicant | SYSMEX CORP. GILMER RD. 6699 RFD Long Grove, IL 60047 -9596 |
| Contact | Chris Stukel |
| Correspondent | Chris Stukel SYSMEX CORP. GILMER RD. 6699 RFD Long Grove, IL 60047 -9596 |
| Product Code | LKM |
| CFR Regulation Number | 864.5200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-07-26 |
| Decision Date | 2001-09-28 |
| Summary: | summary |