The following data is part of a premarket notification filed by Technia Diagnostics Ltd. with the FDA for T3(125) Radioimmunoassay Kit.
| Device ID | K801843 |
| 510k Number | K801843 |
| Device Name: | T3(125) RADIOIMMUNOASSAY KIT |
| Classification | Radioimmunoassay, Total Triiodothyronine |
| Applicant | TECHNIA DIAGNOSTICS LTD. 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 | 1980-08-01 |
| Decision Date | 1980-09-16 |