# K981243: Biostride Free T4 Eia Test Kit

- Pathway: 510(k) (Traditional)
- Applicant: Biostride Diagnostics, Inc.
- Decided: Jun 29, 1998 after 84 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. The FDA summary names its predicate without a number.
- (no number) Abbott AXSYM: named in the summary without a submission number

## Indications for use
This Enzyme immunoassay is used for the quantitative estimation of non-protein bound thyroxine(Free T4) in human serum. This is an in vitro diagnostic device used to assist in the assessment of thyroid function.

Source page: https://510kreport.com/device/K981243
Methodology: https://510kreport.com/methodology