# K082210: Total Bilirubin L3K, Model 295-10 and 295-30

- Pathway: 510(k) (Traditional)
- Applicant: Genzyme Diagnostics P.E.I., Inc.
- Decided: Dec 16, 2008 after 132 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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
For the IN VITRO quantitative measurement of Total Bilirubin in serum and plasma. Measurement of Total Bilirubin is used in the diagnosis and management of liver disease, biliary tract obstruction, various hemolytic diseases and disorders involving the metabolism of bilirubin.

Source page: https://510kreport.com/device/K082210
Methodology: https://510kreport.com/methodology