The following data is part of a premarket notification filed by Roche Diagnostics with the FDA for Cobas U 701 Microscopy Analyzer.
| Device ID | K200811 |
| 510k Number | K200811 |
| Device Name: | Cobas U 701 Microscopy Analyzer |
| Classification | Counter, Urine Particle |
| Applicant | Roche Diagnostics 9115 Hague Road Indianapolis, IN 46256 |
| Contact | Teresa Carrow |
| Correspondent | Teresa Carrow Roche Diagnostics 9115 Hague Road Indianapolis, IN 46256 |
| Product Code | LKM |
| CFR Regulation Number | 864.5200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-03-27 |
| Decision Date | 2020-11-06 |