The following data is part of a premarket notification filed by Nichols Institute Diagnostics with the FDA for Thyroxine-binding Globulin Radioummu.
| Device ID | K842010 |
| 510k Number | K842010 |
| Device Name: | THYROXINE-BINDING GLOBULIN RADIOUMMU |
| Classification | Radioimmunoassay, Thyroxine-binding Globulin |
| Applicant | NICHOLS INSTITUTE DIAGNOSTICS 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 | 1984-05-17 |
| Decision Date | 1984-06-25 |