| K-number | K842528 |
| Device name | AMIZYME-TOXOPLASMA GONDII KIT |
| Applicant | Amico Lab, Inc. |
| Product code | LGD |
| Device class | Class II |
| Decision date | Sep 7, 1984 |
| Decision | Substantially Equivalent |
| Regulation | 866.3780 |
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