# K972012: Cholestech Bun/Creatinine Test System

- Pathway: 510(k) (Traditional)
- Applicant: Cholestech Corp.
- Decided: Jul 24, 1997 after 55 days
- Product code: CDN (Urease, Photometric, 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.
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
The Cholestech LDX system is used for the determination of Blood Urea Nitrogen and Creatinine in whole blood. BUN and Creatinine values are used as indicators of renal function. Blood Urea Nitrogen values are valuable in the diagnosis of renal disorders.

Source page: https://510kreport.com/device/K972012
Methodology: https://510kreport.com/methodology