# K974551: Sealite Sciences, Inc. Aqualite Free T, Assay

- Pathway: 510(k) (Traditional)
- Applicant: Sealite Sciences, Inc.
- Decided: Dec 22, 1997 after 18 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) Nichols Institute Free T₄ Assay: named in the summary without a submission number

## Indications for use
The AquaLite® FT4 Bioluminescent Immunoassay (BIA) Kit (or the AquaLite® FT4 Assay) is an in vitro diagnostic product intended for use in the quantitative measurement of FT4 in human serum in clinical laboratories. Free thyroxine measurements are used to diagnosis and treat diseases of the thyroid.

Source page: https://510kreport.com/device/K974551
Methodology: https://510kreport.com/methodology