The following data is part of a premarket notification filed by Nuclear Diagnostics, Inc. with the FDA for Tipsep-tbg Assay.
| Device ID | K861735 |
| 510k Number | K861735 |
| Device Name: | TIPSEP-TBG ASSAY |
| Classification | Radioimmunoassay, Thyroxine-binding Globulin |
| Applicant | NUCLEAR DIAGNOSTICS, INC. 575 ROBBINS DR. Troy, MI 48083 |
| Contact | Smart, Phd |
| Correspondent | Smart, Phd NUCLEAR DIAGNOSTICS, INC. 575 ROBBINS DR. Troy, MI 48083 |
| Product Code | CEE |
| CFR Regulation Number | 862.1685 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-05-06 |
| Decision Date | 1986-06-13 |