The following data is part of a premarket notification filed by Roche Diagnostics with the FDA for Cobas Integra Bilirubin Direct Gen.2.
| Device ID | K123965 |
| 510k Number | K123965 |
| Device Name: | COBAS INTEGRA BILIRUBIN DIRECT GEN.2 |
| Classification | Diazo Colorimetry, Bilirubin |
| Applicant | Roche Diagnostics 9115 SOUTH HAGUE ROAD Indianapolis, IN 46250 |
| Contact | Susan Hollandbeck |
| Correspondent | Susan Hollandbeck Roche Diagnostics 9115 SOUTH HAGUE ROAD Indianapolis, IN 46250 |
| Product Code | CIG |
| CFR Regulation Number | 862.1110 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-12-26 |
| Decision Date | 2013-02-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07613336121061 | K123965 | 000 |
| 04015630927531 | K123965 | 000 |
| 04015630924912 | K123965 | 000 |