# K062746: Ferritin-Latex, Models 1418-2070, 1418-0279

- Pathway: 510(k) (Traditional)
- Applicant: Medicon Hellas S.A
- Decided: Nov 20, 2006 after 67 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
Longest line of descent: 1 generation back to K030124 (2003). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K030124: Olympus Ferritin Reagent, Olympus America, Inc. (2003) Summary page 2.

## Indications for use
Medicon Ferritin -LATEX reagent is for the determination of Ferritin in human serum and plasma using automated clinical chemistry analyzers. The measurement of ferritin may aid in the diagnosis of diseases affecting iron metabolism.

Source page: https://510kreport.com/device/K062746
Methodology: https://510kreport.com/methodology