The following data is part of a premarket notification filed by Roche Diagnostics with the FDA for Cobas U411 Test System.
| Device ID | K093555 |
| 510k Number | K093555 |
| Device Name: | COBAS U411 TEST SYSTEM |
| Classification | Automated Urinalysis System |
| Applicant | Roche Diagnostics 9115 HAGUE RD. Indianapolis, IN 46250 |
| Contact | Jennifer Tribbett |
| Correspondent | Jennifer Tribbett Roche Diagnostics 9115 HAGUE RD. Indianapolis, IN 46250 |
| Product Code | KQO |
| Subsequent Product Code | CDM |
| Subsequent Product Code | CEN |
| Subsequent Product Code | JIL |
| Subsequent Product Code | JIN |
| Subsequent Product Code | JIO |
| Subsequent Product Code | JIR |
| Subsequent Product Code | JJB |
| Subsequent Product Code | JMT |
| Subsequent Product Code | JRE |
| Subsequent Product Code | LJX |
| CFR Regulation Number | 862.2900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-11-17 |
| Decision Date | 2010-04-02 |
| Summary: | summary |