The following data is part of a premarket notification filed by Pcl-ria, Inc. with the FDA for Thyroxine (t4) 125i.
| Device ID | K812666 |
| 510k Number | K812666 |
| Device Name: | THYROXINE (T4) 125I |
| Classification | Radioimmunoassay, Total Triiodothyronine |
| Applicant | PCL-RIA, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | CDP |
| CFR Regulation Number | 862.1710 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-09-21 |
| Decision Date | 1981-10-02 |