# K981276: N-Assay L D-Bil

- Pathway: 510(k) (Traditional)
- Applicant: Crestat Diagnostics, Inc.
- Decided: May 1, 1998 after 23 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
Longest line of descent: 2 generations back to K912024 (1991). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K970986: Wako Direct Bilirubin V, Wako Chemicals USA, Inc. (1997) Summary page 2.

## Indications for use
The intended use for the N-ASSAY L D-BIL Reagent is for the quantitative determination of serum direct bilirubin in the diagnosis and treatment of various liver diseases. For in vitro diagnostic use only.

Source page: https://510kreport.com/device/K981276
Methodology: https://510kreport.com/methodology