The following data is part of a premarket notification filed by Nuclear Medical Laboratories, Inc. with the FDA for Thyro-shure.
| Device ID | K781296 |
| 510k Number | K781296 |
| Device Name: | THYRO-SHURE |
| Classification | Radioimmunoassay, Thyroid-stimulating Hormone |
| Applicant | NUCLEAR MEDICAL LABORATORIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | JLW |
| CFR Regulation Number | 862.1690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1978-07-27 |
| Decision Date | 1978-08-31 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() THYRO-SHURE 73191537 1152035 Dead/Cancelled |
Nuclear-Medical Laboratories, Inc. 1978-10-30 |