K810967 is an FDA 510(k) clearance for the IN-VITRO TBG RADIOIMMUNOASSAY TEST. This device is classified as a Radioimmunoassay, Thyroxine-binding Globulin (Class II - Special Controls, product code CEE).
Submitted by Clinical Assays, Inc. (Mchenry, US). The FDA issued a Cleared decision on April 23, 1981, 15 days after receiving the submission on April 8, 1981.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1685.
| 510(k) Number | K810967 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 08, 1981 |
| Decision Date | April 23, 1981 |
| Days to Decision | 15 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 |