# K013097: Wiener Lab.Fer-Color AA, Model 5X 20 ML Cat.N 1492003

- Pathway: 510(k) (Traditional)
- Applicant: Wiener Laboratories Saic
- Decided: Nov 13, 2001 after 57 days
- Product code: JIY (Photometric Method, 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
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. The FDA summary names its predicate without a number.
- (no number) RANDOX IRON test system: named in the summary without a submission number

## Indications for use
The “Wiener lab. Fer-Color AA” iron test system is a quantitative in vitro diagnostic device intended to measure iron (non-heme) in serum and plasma. 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/K013097
Methodology: https://510kreport.com/methodology