# K973931: Urea-SL Assay Catalogue Number 239-10, 239-30

- Pathway: 510(k) (Traditional)
- Applicant: Diagnostic Chemicals, Ltd.
- Decided: Nov 24, 1997 after 40 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.
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
For the guantitatch determination of urea in serum. For IN VITRO diagnostic use. The measurement of urea can be clinically useful in the diagnosis of kidney disfinction. Scmm urea plays an important role in the discrimination between prerenal and postrenal azotemia.

Source page: https://510kreport.com/device/K973931
Methodology: https://510kreport.com/methodology