# K974634: Immulite Free T3

- Pathway: 510(k) (Traditional)
- Applicant: Diagnostic Products Corp.
- Decided: Jan 2, 1998 after 21 days
- Product code: CDP (Radioimmunoassay, Total Triiodothyronine)
- Device class: 2
- Regulation: 21 CFR 862.1710
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K932747 (1993). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K932747: Ciba Corning Acs Free T3 Immunoassay, Ciba Corning Diagnostics Corp. (1993) Summary page 1.

## Recalls of this device
- Aug 27, 2013 · Class II · Z-0867-2014: Siemens Healthcare Diagnostics confirmed customer complaints regarding an increase in the number of euthyroid patients (those with normal function of the thyroid) demonstrating values above the recomm
- Aug 27, 2013 · Class II · Z-0868-2014: Siemens Healthcare Diagnostics confirmed customer complaints regarding an increase in the number of euthyroid patients (those with normal function of the thyroid) demonstrating values above the recomm

## Indications for use
DPC's IMMULITE® Free T3 is a chemiluminescent assay for use with the IMMULITE® Automated Immunoassay Analyzer and is designed for the quantitative measurement of Free T3 in serum. It is intended strictly for in vitro diagnostic use as an aid in clinical assessment of thyroid status.

Source page: https://510kreport.com/device/K974634
Methodology: https://510kreport.com/methodology