The following data is part of a premarket notification filed by Hyland Therapeutic Div., Travenol Laboratories with the FDA for Globulin Test, Human Thyroxine Binding.
| Device ID | K781225 |
| 510k Number | K781225 |
| Device Name: | GLOBULIN TEST, HUMAN THYROXINE BINDING |
| Classification | Radioimmunoassay, Thyroxine-binding Globulin |
| Applicant | HYLAND THERAPEUTIC DIV., TRAVENOL LABORATORIES 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 | 1978-07-18 |
| Decision Date | 1978-08-31 |