The following data is part of a premarket notification filed by Roche Diagnostics with the FDA for Cobas U 601 Urinalysis Test System.
| Device ID | K183432 |
| 510k Number | K183432 |
| Device Name: | Cobas U 601 Urinalysis Test System |
| Classification | Method, Enzymatic, Glucose (urinary, Non-quantitative) |
| Applicant | Roche Diagnostics 9115 Hague Road Indianapolis, IN 46250 |
| Contact | Angela Clements |
| Correspondent | Angela Clements Roche Diagnostics 9115 Hague Road Indianapolis, IN 46250 |
| Product Code | JIL |
| Subsequent Product Code | CDM |
| Subsequent Product Code | CEN |
| Subsequent Product Code | JIN |
| Subsequent Product Code | JIO |
| Subsequent Product Code | JIR |
| Subsequent Product Code | JJB |
| Subsequent Product Code | JMT |
| Subsequent Product Code | KQO |
| Subsequent Product Code | LJX |
| CFR Regulation Number | 862.1340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-12-11 |
| Decision Date | 2019-05-07 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04015630932252 | K183432 | 000 |