The following data is part of a premarket notification filed by Rochdiag with the FDA for Cobas Integra C 111.
| Device ID | K063744 |
| 510k Number | K063744 |
| Device Name: | COBAS INTEGRA C 111 |
| Classification | Diazo Colorimetry, Bilirubin |
| Applicant | ROCHDIAG 9115 HAGUE RD. Indianapolis, IN 46250 |
| Contact | Corina Harper |
| Correspondent | Corina Harper ROCHDIAG 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 | 2006-12-18 |
| Decision Date | 2007-01-17 |
| Summary: | summary |