Sienna Biotech, Inc. · Class II · Cleared Oct 31, 1996
| K-number | K961784 |
| Device name | COPALIS ONE IMMUNOASSAY SYSTEM/TOXOPLASMA GONDII/RUBELLA/CMV TOTAL ANTIBODY ASSAYS |
| Applicant | Sienna Biotech, Inc. |
| Product code | LQN |
| Device class | Class II |
| Decision date | Oct 31, 1996 |
| Decision | Substantially Equivalent |
| Regulation | 866.3510 |
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