# K964925: Sealite Sciences, Inc. Aqualite LH

- Pathway: 510(k) (Traditional)
- Applicant: Sealite Sciences, Inc.
- Decided: Jan 22, 1997 after 44 days
- Product code: CEP (Radioimmunoassay, Luteinizing Hormone)
- Device class: 1
- Regulation: 21 CFR 862.1485
- 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 no predicate by number.

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

Source page: https://510kreport.com/device/K964925
Methodology: https://510kreport.com/methodology