Roche Diagnostics Corp. · Class II · Cleared Jul 16, 2003
| K-number | K031880 |
| Device name | AMMONIA/ETHANOL/CO2 CALIBRATOR, CONTROL NORMAL, CONTROL ABNORMAL |
| Applicant | Roche Diagnostics Corp. |
| Product code | JIX |
| Device class | Class II |
| Decision date | Jul 16, 2003 |
| Decision | Substantially Equivalent |
| Regulation | 862.1150 |
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