T3 (RIA) Kit
510(k) K811213
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK811213 | Date29 May 1981 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- CDP
- Device Class
- Class II
- Regulation
- 21 CFR Part 862.1710
- Advisory Committee
- Clinical Chemistry
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 25 Sep 2026
The T3 (RIA) Kit is a radioimmunoassay device used for the quantitative measurement of human 3,5,3' triiodothyronine in serum. This clinical chemistry assay is designed to determine total triiodothyronine levels.
This device is authorized under FDA 510(k) number K811213. It is supplied as an in vitro diagnostic kit and should be stored at 2 to 8 degrees Celsius.
Other devices from Immuno Assay Corp.
Questions
AI-generated answers, 25 Sep 2026
What is the primary use of the T3 (RIA) Kit?
This device is a radioimmunoassay kit designed for the quantitative measurement of human 3,5,3' triiodothyronine in serum. It is used in clinical chemistry settings to determine total triiodothyronine levels.
How should the T3 (RIA) Kit be stored?
To maintain the integrity of the assay components, the kit must be stored at a temperature between 2 and 8 degrees Celsius.
What is the regulatory status of this device?
The T3 (RIA) Kit is authorized under FDA 510(k) number K811213. It is classified under the clinical chemistry specialty and is regulated under 21 CFR 862.1710.