Hitachi Chemical Diagnostics, Inc. · Class II · Cleared Aug 17, 2012
| K-number | K113809 |
| Device name | HITACHI CLINICAL ANALYZER S TEST REGENT CARTRIDGE C-REACTIVE PROTEIN (CRP) |
| Applicant | Hitachi Chemical Diagnostics, Inc. |
| Product code | DCN |
| Device class | Class II |
| Decision date | Aug 17, 2012 |
| Decision | Substantially Equivalent |
| Regulation | 866.5270 |
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