# K935847: Axsym Ferritin

- Pathway: 510(k) (Traditional)
- Applicant: Abbott Laboratories
- Decided: Jun 21, 1994 after 195 days
- Product code: DBF (Ferritin, Antigen, Antiserum, Control)
- Device class: 2
- Regulation: 21 CFR 866.5340
- 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
- K040879: Quantex Ferritin (2004), 1 descendant of its own
- K052617: Ferritin Lit Assay, Catalog NO. 7010; Ferritin Calibrator Set, Catalog NO. 7510; Ferritin Controls, Level-L & Level-H, (2006), 0 descendants of its own

Source page: https://510kreport.com/device/K935847
Methodology: https://510kreport.com/methodology