# K981106: Urea Nitrogen (Bun) Liquid Reagent

- Pathway: 510(k) (Traditional)
- Applicant: Teco Diagnostics
- Decided: Apr 16, 1998 after 21 days
- Product code: CDQ (Urease And Glutamic Dehydrogenase, 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
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’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K060120: Teco CX3 Reagent Set for Synchron CX System (2006), 0 descendants of its own

## Indications for use
For the Kinetic Quantitative determination of Urea Nitrogen (BUN) in serum. Urea Nitrogen determination is an indicator of liver and kidney functions, such as Nephritis, Acute Liver Destruction and Urinary Obstruction.

Source page: https://510kreport.com/device/K981106
Methodology: https://510kreport.com/methodology