# K991244: Total Iron, Models FE 109-01, FE 109-02

- Pathway: 510(k) (Traditional)
- Applicant: A.P. Total Care, Inc.
- Decided: May 25, 1999 after 43 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 total iron reagents: Buffer, pH 4.5 (R1), product No. FE109-01 and Color reagent, product No. FE109-02 are intended for Invitro Diagnostic use in the automated, quantitative determination of Total Iron in serum, or plasma.

Source page: https://510kreport.com/device/K991244
Methodology: https://510kreport.com/methodology