The following data is part of a premarket notification filed by Immunotech Corp. with the FDA for Endab Thyroid Uptake.
| Device ID | K822684 |
| 510k Number | K822684 |
| Device Name: | ENDAB THYROID UPTAKE |
| Classification | Radioimmunoassay, Thyroxine-binding Globulin |
| Applicant | IMMUNOTECH CORP. 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 | 1982-09-03 |
| Decision Date | 1982-10-08 |