Axis-Shield Diagnostics, Ltd. · Class II · Cleared May 2, 2002
| K-number | K020349 |
| Device name | ABBOTT AXSYM ANTI-THYROGLOBULIN, MODELS 5F5B COMPRISING STANDARD/CALIBRATORS |
| Applicant | Axis-Shield Diagnostics, Ltd. |
| Product code | JZO |
| Device class | Class II |
| Decision date | May 2, 2002 |
| Decision | Substantially Equivalent |
| Regulation | 866.5870 |
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