The following data is part of a premarket notification filed by Radioimmunoassay, Inc. with the FDA for 125 I-t3 Uptake Reagent.
| Device ID | K780671 |
| 510k Number | K780671 |
| Device Name: | 125 I-T3 UPTAKE REAGENT |
| Classification | Radioimmunoassay, Thyroxine-binding Globulin |
| Applicant | RADIOIMMUNOASSAY, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | CEE |
| CFR Regulation Number | 862.1685 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1978-04-24 |
| Decision Date | 1978-06-06 |