# K981581: IRON

- Pathway: 510(k) (Traditional)
- Applicant: Abbott Laboratories
- Decided: Jun 8, 1998 after 35 days
- Product code: CFM (Bathophenanthroline, Colorimetry, Iron (Non-Heme))
- Device class: 1
- Regulation: 21 CFR 862.1410
- 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 K854298 (1985). 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)
- K854298: IRON, Boehringer Mannheim Corp. (1985) Summary page 1.

## Indications for use
The Iron assay is used for the quantitation of iron in human serum. Iron (non-heme) measurements are used in the diagnosis and treatment of diseases such as iron deficiency anemia, hemochromatosis (a disease associated with widespread deposit in the tissues of two iron-containing pigments, hemosiderin and hemofuscin, and characterized by pigmentation of the skin), and chronic renal disease.

Source page: https://510kreport.com/device/K981581
Methodology: https://510kreport.com/methodology