The following data is part of a premarket notification filed by Organon, Inc. with the FDA for Oreia-q-dig.
| Device ID | K802358 |
| 510k Number | K802358 |
| Device Name: | OREIA-Q-DIG |
| Classification | Enzyme Immunoassay, Digoxin |
| Applicant | ORGANON, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | KXT |
| CFR Regulation Number | 862.3320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-09-26 |
| Decision Date | 1980-10-10 |