# K020548: Free T4 (Thytoxine) Microplate Eia Test Models # 1225-300

- Pathway: 510(k) (Traditional)
- Applicant: Monobind
- Decided: Apr 5, 2002 after 45 days
- Product code: CEC (Radioimmunoassay, Free Thyroxine)
- Device class: 2
- Regulation: 21 CFR 862.1695
- 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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
Free T4 test device is an in vitro diagnostic test system for the quantitative determination of circulating Free T4 (non-protein bound Thyroxine) in human serum. It is intended strictly for in-vitro diagnostic use as an aid to clinical diagnosis of thyroid diseases.

Source page: https://510kreport.com/device/K020548
Methodology: https://510kreport.com/methodology