# K063208: Magnesium Assay (XB), Models 125-12, 125-50 and 125-S7

- Pathway: 510(k) (Traditional)
- Applicant: Diagnostic Chemicals, Ltd.
- Decided: Jan 19, 2007 after 88 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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The Diagnostic Chemicals Limited Magnesium Assay (XB) is for the quantitative determination of magnesium in human serum. Magnesium measurements are used in the diagnosis and treatment of hypomagnesemia (abnormally low levels of magnesium) and hypermagnesemia (abnormally high levels of magnesium). This device is intended for professional use and INVITRO diagnostic use only. The Diagnostic Chemicals Limited Magnesium Assay (XB) Standard is used for the calibration of the Diagnostic Chemicals Limited Magnesium Assay (XB) when used for the quantitative determination of magnesium in human serum.

Source page: https://510kreport.com/device/K063208
Methodology: https://510kreport.com/methodology