Axis-Shield Diagnostics, Ltd. · Class II · Cleared Sep 25, 2009
| K-number | K083868 |
| Device name | ARCHITECT ANTI-CCP (100 TEST), ARCHITECT ANTI-CCP (500 TEST), MODELS 1P65-25, 1P65-35 |
| Applicant | Axis-Shield Diagnostics, Ltd. |
| Product code | NHX |
| Device class | Class II |
| Decision date | Sep 25, 2009 |
| Decision | Substantially Equivalent |
| Regulation | 866.5775 |
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