The following data is part of a premarket notification filed by Nuclear Diagnostics, Inc. with the FDA for Tipsep-t4(ria) T4 Radioimmunoassay.
| Device ID | K792599 |
| 510k Number | K792599 |
| Device Name: | TIPSEP-T4(RIA) T4 RADIOIMMUNOASSAY |
| Classification | Radioimmunoassay, Total Thyroxine |
| Applicant | NUCLEAR DIAGNOSTICS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | CDX |
| CFR Regulation Number | 862.1700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1979-12-18 |
| Decision Date | 1980-01-16 |