OREIA-T4
Radioimmunoassay, Total Thyroxine
ORGANON, INC.
The following data is part of a premarket notification filed by Organon, Inc. with the FDA for Oreia-t4.
Pre-market Notification Details
| Device ID | K780308 |
| 510k Number | K780308 |
| Device Name: | OREIA-T4 |
| Classification | Radioimmunoassay, Total Thyroxine |
| Applicant | ORGANON, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | CDX |
| CFR Regulation Number | 862.1700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1978-02-23 |
| Decision Date | 1978-04-12 |
Trademark Results [OREIA-T4]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 OREIA-T4 73235743 1167052 Dead/Cancelled |
Organon Inc. 1979-10-18 |
 OREIA-T4 73161505 1165091 Dead/Cancelled |
Organon Inc. 1978-03-09 |
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