# K982954: Free T4 Microwell Eia, Model #7019

- Pathway: 510(k) (Traditional)
- Applicant: Biomerica, Inc.
- Decided: Sep 24, 1998 after 31 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 EIA can be used as an in vitro Diagnostic test system for the quantitative determination of non-protein-bound (Free) circulating Thyroxine (T4) in human serum. Measurements obtained by this device are used in the diagnosis and treatment of thyroid diseases. It is not suitable for use in determination of thyroid status in neonatal patients.

Source page: https://510kreport.com/device/K982954
Methodology: https://510kreport.com/methodology