# K902834: Abbott Imx Free T4

- Pathway: 510(k) (Traditional)
- Applicant: Abbott Laboratories
- Decided: Sep 7, 1990 after 71 days
- Product code: CEC (Radioimmunoassay, Free Thyroxine)
- Device class: 2
- Regulation: 21 CFR 862.1695
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 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
- K030329: Fastpack Free T4 Immunoassay (2003), 0 descendants of its own

## Recalls of this device
- May 30, 2003 · Not classified · Z-1131-03: The Free T4 Controls, may yield control values that are high and outside of the package insert ranges.

Source page: https://510kreport.com/device/K902834
Methodology: https://510kreport.com/methodology