# K960550: Active T3 Ria

- Pathway: 510(k) (Traditional)
- Applicant: Diagnostic Systems Laboratories, Inc.
- Decided: Mar 6, 1996 after 27 days
- Product code: CDP (Radioimmunoassay, Total Triiodothyronine)
- Device class: 2
- Regulation: 21 CFR 862.1710
- 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) DPC Coat-a-Count Total T3 Ria: named in the summary without a submission number

## Indications for use
The DSL ACTIVE™ T3 RIA assay is intended for the quantitative determination of Total T3 in human serum. The measurement of T3 is used in the diagnosis and treatment og thyroid diseases such as hyperthyroidism.

Source page: https://510kreport.com/device/K960550
Methodology: https://510kreport.com/methodology