# K962355: Free Triiodothyronine (FT3) Assay for the Technicon Immuno 1 System (in-Vitro Diagnostic System)

- Pathway: 510(k) (Traditional)
- Applicant: Bayer Corp.
- Decided: Jul 12, 1996 after 24 days
- Product code: CDP (Radioimmunoassay, Total Triiodothyronine)
- Device class: 2
- Regulation: 21 CFR 862.1710
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) INCSTAR Clinical Assays GammaCoat™ Free T3 RIA kit: named in the summary without a submission number

## Indications for use
This in vitro method is intended to quantitatively measure Free T3 in human serum on a Technicon Immuno-1 system. Measurements of Free T3 are used in the diagnosis and treatment of thyroid diseases.

Source page: https://510kreport.com/device/K962355
Methodology: https://510kreport.com/methodology