The following data is part of a premarket notification filed by Nuclear Diagnostics, Inc. with the FDA for Stiksep-t3 Kit.
| Device ID | K780486 |
| 510k Number | K780486 |
| Device Name: | STIKSEP-T3 KIT |
| Classification | Radioimmunoassay, Thyroxine-binding Globulin |
| Applicant | NUCLEAR DIAGNOSTICS, 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 | 1978-03-27 |
| Decision Date | 1978-04-28 |