# K832236: Sigma Procedure #550 Determ. Bilirub

- Pathway: 510(k) (Traditional)
- Applicant: Sigma Chemical Co.
- Decided: Aug 31, 1983 after 51 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.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K980646: IL Synthesis--Addition of Bilirubin as a Measured Parameter for Neonate Whole Blood Samples (1998), 0 descendants of its own

Source page: https://510kreport.com/device/K832236
Methodology: https://510kreport.com/methodology