| K-number | K802693 |
| Device name | OREIA-Q-TY, ENZYME IMMUNOASSAY |
| Applicant | Organon, Inc. |
| Product code | KLI |
| Device class | Class II |
| Decision date | Dec 10, 1980 |
| Decision | Substantially Equivalent |
| Regulation | 862.1700 |
AI extraction for this record is queued and will appear within 24 hours. View full FDA record →
View the full FDA submission: accessdata.fda.gov