| K-number | K913122 |
| Device name | DIRECTIGEN 1-2-3(TM) HCG TEST |
| Applicant | Quidel Corp. |
| Product code | JHI |
| Device class | Class II |
| Decision date | Aug 16, 1991 |
| Decision | Substantially Equivalent |
| Regulation | 862.1155 |
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