# K012065: Wiener Lab. Creatinina Cinetica AA

- Pathway: 510(k) (Traditional)
- Applicant: Wiener Laboratories Saic
- Decided: Oct 10, 2001 after 100 days
- Product code: JFY (Enzymatic Method, Creatinine)
- Device class: 2
- Regulation: 21 CFR 862.1225
- 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) RANDOX CREATININE Test system: named in the summary without a submission number
- (no number) DMA CREATININE Test system: named in the summary without a submission number

## Indications for use
The “Wiener lab. Creatinina cinética AA” creatinine test system is a device intended to measure creatinine levels in plasma and urine. Creatinine measurements are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis, and as a calculation basis for measuring other urine analytes.

Source page: https://510kreport.com/device/K012065
Methodology: https://510kreport.com/methodology