# K860137: Enzymun-Test Ferritin

- Pathway: 510(k) (Traditional)
- Applicant: Boehringer Mannheim Corp.
- Decided: Mar 28, 1986 after 73 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
- K964282: Tina-Quant Ferritin Assay (1997), 1 descendant of its own
- K100538: Tina-Quant Ferritin Gen. 4 (2010), 0 descendants of its own

Source page: https://510kreport.com/device/K860137
Methodology: https://510kreport.com/methodology