# K040973: Bun Reagent

- Pathway: 510(k) (Traditional)
- Applicant: Genchem, Inc.
- Decided: Dec 27, 2004 after 257 days
- Product code: CDS (Electrode, Ion Specific, Urea Nitrogen)
- Device class: 2
- Regulation: 21 CFR 862.1770
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K761061 (1977). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K761061: Blood-Urea-Nitrogen (Bun) Analyzer 2, Beckman Instruments, Inc. (1977) Summary page 1.

## Indications for use
The BUN Reagent is to be used for the quantitative determination of urea nitrogen in serum, plasma and urine on the Beckman SYNCHRON CX3® System to aid in the diagnosis of renal function and pre renal disease states, such as cardiac decompensation and others.

Source page: https://510kreport.com/device/K040973
Methodology: https://510kreport.com/methodology