# K970085: Sealite Sciences Aqualite FSH

- Pathway: 510(k) (Traditional)
- Applicant: Sealite Sciences, Inc.
- Decided: Feb 14, 1997 after 35 days
- Product code: CGJ (Radioimmunoassay, Follicle-Stimulating Hormone)
- Device class: 1
- Regulation: 21 CFR 862.1300
- 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) SeaLite Sciences, Inc. AquaLite® FSH Assay: named in the summary without a submission number

## Indications for use
The AquaLite® FSH Bioluminescent Immunoassay (BIA) Kit (or the AquaLite® FSH assay) is intended to be used in clinical laboratories for the quantitative determination of human FSH in sera and plasma. The AquaLite® FSH assay is for in vitro diagnostic use.

Source page: https://510kreport.com/device/K970085
Methodology: https://510kreport.com/methodology