The following data is part of a premarket notification filed by Sysmex America, Inc. with the FDA for Sysmex Ud-10, Fully Automated Urine Particle Digital Imaging Device.
| Device ID | K182062 |
| 510k Number | K182062 |
| Device Name: | Sysmex UD-10, Fully Automated Urine Particle Digital Imaging Device |
| Classification | Device, Automated Cell-locating |
| Applicant | Sysmex America, Inc. 577 Aptakisic Road Lincolnshire, IL 60069 |
| Contact | Jessica Rivera-montejo |
| Correspondent | Jessica Rivera-montejo Sysmex America, Inc. 577 Aptakisic Road Lincolnshire, IL 60069 |
| Product Code | JOY |
| CFR Regulation Number | 864.5260 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-08-01 |
| Decision Date | 2018-10-30 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04987562444779 | K182062 | 000 |