# K012326: Wiener Lab.MG-Color AA, Model 2X50 ML Cat. N 1580001

- Pathway: 510(k) (Traditional)
- Applicant: Wiener Laboratories Saic
- Decided: Nov 8, 2001 after 108 days
- Product code: JGJ (Photometric Method, Magnesium)
- Device class: 1
- Regulation: 21 CFR 862.1495
- 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) ROCHE MAGNESIUM test system: named in the summary without a submission number

## Indications for use
The “Wiener lab. Mg-color AA’ test system is a device intended to be used in the quantitative determination of magnesium in human serum, plasma and urine. Magnesium measurement is used in the diagnosis and treatment of hypomagnesemia (abnormally low plasma levels of magnesium) and hypermagnesemia (abnormally high plasma levels of magnesium).

Source page: https://510kreport.com/device/K012326
Methodology: https://510kreport.com/methodology