Kamiya Biomedical Co. · Class II · Cleared Jun 27, 2003
| K-number | K030687 |
| Device name | K-ASSAY D-DIMER, K-ASSAY D-DIMER CALIBRATOR, MODELS KAI-090; KAJ-091C |
| Applicant | Kamiya Biomedical Co. |
| Product code | DAP |
| Device class | Class II |
| Decision date | Jun 27, 2003 |
| Decision | Substantially Equivalent |
| Regulation | 864.7320 |
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