# K974604: Randox Iron

- Pathway: 510(k) (Traditional)
- Applicant: Randox Laboratories, Ltd.
- Decided: Jan 6, 1998 after 27 days
- Product code: JMO (Ferrozine (Colorimetric) Iron Binding Capacity)
- Device class: 1
- Regulation: 21 CFR 862.1415
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The Randox Laboratories Limited Iron Test Kit is an in vitro diagnostic reagent for the quantitative determination of iron in human serum. The method is based on the reaction of ferrous iron with the chromogen ferrozine to produce a coloured chromophore which can be detected at 570nm. Serum iron may be used to distinguish between different types of anaemias and to identify conditions involving iron deficiency. This test kit must be used by suitably qualified laboratory personnel under appropriate laboratory conditions.

Source page: https://510kreport.com/device/K974604
Methodology: https://510kreport.com/methodology