Organon, Inc. · Class II · Cleared Dec 8, 1983
| K-number | K832801 |
| Device name | OREIA II B-HCG, ENZYME INNUNOASSAY |
| Applicant | Organon, Inc. |
| Product code | JHI |
| Device class | Class II |
| Decision date | Dec 8, 1983 |
| Decision | Substantially Equivalent |
| Regulation | 862.1155 |
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