# K984122: Wako L-Type Uibc, Wako Uibc Calibrator

- Pathway: 510(k) (Traditional)
- Applicant: Wako Chemicals USA, Inc.
- Decided: Jan 20, 1999 after 63 days
- Product code: JQF (Bathophenanthroline, 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. The FDA summary names its predicate without a number.
- (no number) Wako UIBC manual test: named in the summary without a submission number

## Indications for use
The Wako L-type UIBC test is an in vitro diagnostic assay for the quantitative determination of iron in serum.

Source page: https://510kreport.com/device/K984122
Methodology: https://510kreport.com/methodology