# K012329: Wiener Lab.Albumina AA, Models 6X60 ML Cat N 1690008, 6X120 ML Cat 1009300

- Pathway: 510(k) (Traditional)
- Applicant: Wiener Laboratories Saic
- Decided: Sep 21, 2001 after 60 days
- Product code: CIX (Bromcresol Green Dye-Binding, Albumin)
- Device class: 2
- Regulation: 21 CFR 862.1035
- 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) ABBOTT ALBUMIN BCG test system: named in the summary without a submission number

## Indications for use
The “Wiener lab. Albumina AA” albumin test system is a quantitative in vitro diagnostic device intended to be used in the quantitative determination of albumin in human sera. Albumin measurements are used in the diagnosis and treatment of numerous diseases involving primarily the liver or kidneys.

Source page: https://510kreport.com/device/K012329
Methodology: https://510kreport.com/methodology