# K022962: Wiener Lab. Bilirrubina Total AA

- Pathway: 510(k) (Traditional)
- Applicant: Wiener Laboratories Saic
- Decided: Nov 1, 2002 after 56 days
- Product code: CIG (Diazo Colorimetry, Bilirubin)
- Device class: 2
- Regulation: 21 CFR 862.1110
- 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) DMA Total Bilirubin Plus test system (Cat. No 1245): named in the summary without a submission number

## Indications for use
The “Wiener lab. Bilirrubina Total AA” test system is a quantitative in vitro diagnostic device intended to be used in the quantitative determination of total bilirubin in human sera and heparinized plasmas on both manual and automated systems. Measurements of the levels of bilirubin, an organic compound formed during the normal and abnormal destruction of red blood cells, are used in the diagnosis and treatment of liver, hemolytic, hematological, and metabolic disorders, including hepatitis and gall bladder block.

Source page: https://510kreport.com/device/K022962
Methodology: https://510kreport.com/methodology