Genzyme Diagnostics · Class II · Cleared Nov 25, 1996
| K-number | K964155 |
| Device name | CONTRAST HCG URINE/SERUM TEST AND RAPID HCG URINE/SERUM TEST |
| Applicant | Genzyme Diagnostics |
| Product code | JHI |
| Device class | Class II |
| Decision date | Nov 25, 1996 |
| Decision | Substantially Equivalent |
| Regulation | 862.1155 |
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