# K993219: Wako Bilirubin Calibrator

- Pathway: 510(k) (Traditional)
- Applicant: Wako Chemicals USA, Inc.
- Decided: Nov 9, 1999 after 43 days
- Product code: JIS (Calibrator, Primary)
- Device class: 2
- Regulation: 21 CFR 862.1150
- 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 Bilirubin Standard: named in the summary without a submission number

## Indications for use
A calibrator is a device intended to be used with the Wako vanadate bilirubin methods to establish points of reference for the determination of total and direct bilirubin values in human specimens.

Source page: https://510kreport.com/device/K993219
Methodology: https://510kreport.com/methodology