Roche Diagnostics Corp. · Class II · Cleared May 12, 2008
| K-number | K080607 |
| Device name | CALIBRATOR FOR AUTOMATED SYSTEMS (C.F.A.S.) PROTEINS WITH MODEL 11355279160 |
| Applicant | Roche Diagnostics Corp. |
| Product code | JIX |
| Device class | Class II |
| Decision date | May 12, 2008 |
| Decision | Substantially Equivalent |
| Regulation | 862.1150 |
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