K781225 is an FDA 510(k) clearance for the GLOBULIN TEST, HUMAN THYROXINE BINDING. This device is classified as a Radioimmunoassay, Thyroxine-binding Globulin (Class II - Special Controls, product code CEE).
Submitted by Hyland Therapeutic Div., Travenol Laboratories (Mchenry, US). The FDA issued a Cleared decision on August 31, 1978, 44 days after receiving the submission on July 18, 1978.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1685.
| 510(k) Number | K781225 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 18, 1978 |
| Decision Date | August 31, 1978 |
| Days to Decision | 44 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | — |
| Product Code | CEE — Radioimmunoassay, Thyroxine-binding Globulin |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1685 |