Axis-Shield Diagnostics, Ltd. · Class II · Cleared Mar 20, 2007
| K-number | K063347 |
| Device name | AXSYM ANTI-CCP REAGENT, STANDARD CALIBRATOR AND CONTROL KITS, MODELS 3L91-20, 3L91-01 AND 3L91-10 |
| Applicant | Axis-Shield Diagnostics, Ltd. |
| Product code | NHX |
| Device class | Class II |
| Decision date | Mar 20, 2007 |
| Decision | Substantially Equivalent |
| Regulation | 866.5775 |
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