# K032697: Dimension Total Triiodothyronine Calibrator (RC414)

- Pathway: 510(k) (Traditional)
- Applicant: Dade Behring, Inc.
- Decided: Nov 7, 2003 after 66 days
- Product code: JIS (Calibrator, Primary)
- Device class: 2
- Regulation: 21 CFR 862.1150
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K953160 (1995). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K953160: OPUS T3, Behring Diagnostics, Inc. (1995) Summary page 1.

## Most influential descendants
- K061885: Dimension Vista System Total Triiodothyronine Calibrator, Model KC250 (2006), 0 descendants of its own

## Indications for use
The Dimension@Total Triiodothyronine(T3) Calibrator (RC414) is intended for use in the calibration of the Total Triiodothyronine (T3) method on the Dimension@clinical chemistry system with the HeterogeneousImmunoassay Module.

Source page: https://510kreport.com/device/K032697
Methodology: https://510kreport.com/methodology