← Product Code [JGJ](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JGJ) · K863002

# EMDS(TM) MAGNESIUM TESTPACKS, #67671/95 (K863002)

_Em Diagnostic Systems, Inc. · JGJ · Aug 19, 1986 · Clinical Chemistry · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JGJ/K863002

## Device Facts

- **Applicant:** Em Diagnostic Systems, Inc.
- **Product Code:** [JGJ](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JGJ.md)
- **Decision Date:** Aug 19, 1986
- **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/K863002](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JGJ/K863002)

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