# K953160: OPUS T3

- Pathway: 510(k) (Traditional)
- Applicant: Behring Diagnostics, Inc.
- Decided: Aug 24, 1995 after 48 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.
2 later devices descend 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)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K032697: Dimension Total Triiodothyronine Calibrator (RC414) (2003), 1 descendant of its own
- K061885: Dimension Vista System Total Triiodothyronine Calibrator, Model KC250 (2006), 0 descendants of its own

Source page: https://510kreport.com/device/K953160
Methodology: https://510kreport.com/methodology