K093555 is an FDA 510(k) clearance for the COBAS U411 TEST SYSTEM. This device is classified as a Automated Urinalysis System (Class I - General Controls, product code KQO).
Submitted by Roche Diagnostics (Indianapolis, US). The FDA issued a Cleared decision on April 2, 2010, 136 days after receiving the submission on November 17, 2009.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.2900.
| 510(k) Number | K093555 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 17, 2009 |
| Decision Date | April 02, 2010 |
| Days to Decision | 136 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | KQO — Automated Urinalysis System |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 862.2900 |