Roche Diagnostics Corp. · Class II · Cleared Dec 22, 2006
| K-number | K063543 |
| Device name | COBAS INTEGRA BILIRUBIN SPECIAL AND ROCHE/HITACHI BILRUBIN TOTAL, MODELS 20737496 322, 03261638 190, AND 11822713 226 |
| Applicant | Roche Diagnostics Corp. |
| Product code | CIG |
| Device class | Class II |
| Decision date | Dec 22, 2006 |
| Decision | Substantially Equivalent |
| Regulation | 862.1110 |
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