Axis-Shield Diagnostics, Ltd. · Class I · Cleared Sep 29, 2004
| K-number | K041866 |
| Device name | ABBOTT AXSYM TESTOSTERONE MICROPARTICLE ENZYME IMMUNOASSAY (MEIA) |
| Applicant | Axis-Shield Diagnostics, Ltd. |
| Product code | CDZ |
| Device class | Class I |
| Decision date | Sep 29, 2004 |
| Decision | Substantially Equivalent |
| Regulation | 862.1680 |
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