The following data is part of a premarket notification filed by Roche Diagnostics with the FDA for Cobas Integra 400/800 Bilirubin Total.
| Device ID | K081193 |
| 510k Number | K081193 |
| Device Name: | COBAS INTEGRA 400/800 BILIRUBIN TOTAL |
| Classification | Diazo Colorimetry, Bilirubin |
| 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 | CIG |
| CFR Regulation Number | 862.1110 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-04-28 |
| Decision Date | 2009-01-16 |
| Summary: | summary |