← Product Code [JGJ](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JGJ) · K912825

# MAGNESIUM ASSAY KIT, CAT.# 100-12 (K912825)

_Diagnostic Chemicals, Ltd. (Usa) · JGJ · Jul 26, 1991 · Clinical Chemistry · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JGJ/K912825

## Device Facts

- **Applicant:** Diagnostic Chemicals, Ltd. (Usa)
- **Product Code:** [JGJ](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JGJ.md)
- **Decision Date:** Jul 26, 1991
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 862.1495
- **Device Class:** Class 1
- **Review Panel:** Clinical Chemistry

## Regulatory Identification

A magnesium test system is a device intended to measure magnesium levels in serum and plasma. Magnesium measurements are used in the diagnosis and treatment of hypomagnesemia (abnormally low plasma levels of magnesium) and hypermagnesemia (abnormally high plasma levels of magnesium).

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**Source:** [https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JGJ/K912825](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JGJ/K912825)

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