# K971269: DSL Active T4 Eia

- Pathway: 510(k) (Traditional)
- Applicant: Diagnostic Systems Laboratories, Inc.
- Decided: May 22, 1997 after 48 days
- Product code: KLI (Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine)
- Device class: 2
- Regulation: 21 CFR 862.1700
- 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) DSL Active™ T4 Ria: named in the summary without a submission number

## Indications for use
The DSL-10-3200 T4 Enzymeimmunoassay (EIA) Kit provides materials for the quantitative measurement of T4 in serum. This assay is intended for in vitro diagnostic use in the diagnosis and treatment of thyroid disease.

Source page: https://510kreport.com/device/K971269
Methodology: https://510kreport.com/methodology