# K984119: Wako L-Type FE, Wako L-Type Calibrator

- Pathway: 510(k) (Traditional)
- Applicant: Wako Chemicals USA, Inc.
- Decided: Jan 15, 1999 after 58 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
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) Wako Fe B test: named in the summary without a submission number

## Indications for use
For use as an aid in the diagnosis and monitoring of diseases such as iron deficiency anemia, hemochromatosis and chronic liver disease.

Source page: https://510kreport.com/device/K984119
Methodology: https://510kreport.com/methodology