K200811 is an FDA 510(k) clearance for the cobas u 701 microscopy analyzer. This device is classified as a Counter, Urine Particle (Class II - Special Controls, product code LKM).
Submitted by Roche Diagnostics (Indianapolis, US). The FDA issued a Cleared decision on November 6, 2020, 224 days after receiving the submission on March 27, 2020.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.5200.
| 510(k) Number | K200811 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 27, 2020 |
| Decision Date | November 06, 2020 |
| Days to Decision | 224 days |
| Submission Type | Traditional |
| Review Panel | Hematology (HE) |
| Summary | Summary PDF |
| Product Code | LKM — Counter, Urine Particle |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 864.5200 |