# K991761: Magnesium Product No's, 112-01, 112-02

- Pathway: 510(k) (Traditional)
- Applicant: A.P. Total Care, Inc.
- Decided: Sep 2, 1999 after 101 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
This Magnesium procedure is intended for Invitro Diagnostic use in the automated, quantitative determination of Magnesium in serum. Magnesium measurements are use in the diagnostics and treatment of hypomagnesemia (abnormally low levels of serum magnesium) and hypermagnesimia (abnormally high levels of serum magnesium).

Source page: https://510kreport.com/device/K991761
Methodology: https://510kreport.com/methodology