# K900883: Enzymun Test (R) FT4 (Free Thyroxine)

- Pathway: 510(k) (Traditional)
- Applicant: Boehringer Mannheim Corp.
- Decided: May 15, 1990 after 78 days
- Product code: CEC (Radioimmunoassay, Free Thyroxine)
- Device class: 2
- Regulation: 21 CFR 862.1695
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
6 later devices descend from it; 1 cites it directly.
0 of 7 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
- K961489: Elecsys FT4 Assay (1996), 5 descendants of its own
- K131244: Elecsys FT4 II Assay, Elecsys FT4 II Calset (2014), 2 descendants of its own
- K220456: Elecsys FT4 IV (2023), 0 descendants of its own
- K181233: Elecsys FT4 III (2018), 0 descendants of its own
- K132058: Vidas FT4 (2015), 0 descendants of its own

Source page: https://510kreport.com/device/K900883
Methodology: https://510kreport.com/methodology