# K012260: Wiener Lab. Urea UV Cinetica AA

- Pathway: 510(k) (Traditional)
- Applicant: Wiener Laboratories Saic
- Decided: Sep 19, 2001 after 63 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. The FDA summary names its predicate without a number.
- (no number) DMA BUN-KINETIC, UREASE PROCEDURE test system (Cat. N° 1770): named in the summary without a submission number

## Indications for use
The “Wiener lab. Urea UV cinética AA” urea test system is a device intended to measure urea (urea nitrogen) levels in human serum or plasma. Measurements obtained by this device are used in the diagnosis and treatment of certain renal and metabolic diseases.

Source page: https://510kreport.com/device/K012260
Methodology: https://510kreport.com/methodology