# K981192: MG

- Pathway: 510(k) (Traditional)
- Applicant: Abbott Laboratories
- Decided: May 1, 1998 after 29 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
Longest line of descent: 1 generation back to K811194 (1981). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K901758: Roche Reagent for Magnesium, Roche Diagnostic Systems, Inc. (1990) Summary page 1.
- K811194: Hitachi 705 Automatic Blood Chemistry, Boehringer Mannheim Corp. (1981) Summary page 1.

## Indications for use
The Magnesium assay is used for the quantitation of magnesium in serum, plasma, or urine. Magnesium measurements are used in the diagnosis and treatment of hypomagnesemia (abnormally low serum levels of magnesium) and hypermagnesemia (abnormally high serum levels of magnesium).

Source page: https://510kreport.com/device/K981192
Methodology: https://510kreport.com/methodology