The following data is part of a premarket notification filed by Sysmex America, Inc. with the FDA for Sysmex Uf-5000 Fully Automated Urine Particle Analyzer.
| Device ID | K171883 |
| 510k Number | K171883 |
| Device Name: | Sysmex UF-5000 Fully Automated Urine Particle Analyzer |
| Classification | Counter, Urine Particle |
| Applicant | Sysmex America, Inc. 577 Aptakisic Road Lincolnshire, IL 60069 |
| Contact | Sharita Brooks |
| Correspondent | Sharita Brooks Sysmex America, Inc. 577 Aptakisic Road Lincolnshire, IL 60069 |
| Product Code | LKM |
| CFR Regulation Number | 864.5200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-06-23 |
| Decision Date | 2018-04-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04987562440139 | K171883 | 000 |