The following data is part of a premarket notification filed by Nuclear Diagnostics, Inc. with the FDA for Serum Thyrotropin Assay Kit, Tipsep-.
| Device ID | K833713 |
| 510k Number | K833713 |
| Device Name: | SERUM THYROTROPIN ASSAY KIT, TIPSEP- |
| Classification | Radioimmunoassay, Thyroid-stimulating Hormone |
| Applicant | NUCLEAR DIAGNOSTICS, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | JLW |
| CFR Regulation Number | 862.1690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-10-21 |
| Decision Date | 1983-12-29 |