# K972073: Total Bilirubin Reagent

- Pathway: 510(k) (Traditional)
- Applicant: Carolina Liquid Chemistries Corp.
- Decided: Jun 24, 1997 after 21 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
Total Bilirubin is intended for the guantitative determination of total bilirubin in serum using Beckman SYNCHRON CX Clinical Systems. The results 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/K972073
Methodology: https://510kreport.com/methodology