# K023550: Wiener Lab Uricostat Enzimatico AA Liquida

- Pathway: 510(k) (Traditional)
- Applicant: Wiener Laboratories Saic
- Decided: Dec 9, 2002 after 48 days
- Product code: KNK (Acid, Uric, Uricase (Colorimetric))
- Device class: 1
- Regulation: 21 CFR 862.1775
- 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) Wiener lab. Uricostat enzimatico AA test system (Cat. No. 1840106): named in the summary without a submission number

## Indications for use
The “Wiener lab. Uricostat enzimático AA Liquida” test system is a quantitative in vitro diagnostic device intended to be used in the determination of uric acid in human sera and heparinized plasmas on both manual and automated systems. Measurements of serum uric acid, are used in the diagnosis and treatment of numerous renal and metabolic disorders, including renal failure, gout, leukemia, psoriasis, starvation or other wasting conditions and of patients under treatment with cytotoxic drugs.

Source page: https://510kreport.com/device/K023550
Methodology: https://510kreport.com/methodology