← Product Code [JGJ](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JGJ) · K926144

# URINE MAGNESIUM METHOD FOR TECHNICON CHEM SYSTEMS (K926144)

_Heraeus Kulzer, Inc. · JGJ · Jan 27, 1993 · Clinical Chemistry · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JGJ/K926144

## Device Facts

- **Applicant:** Heraeus Kulzer, Inc.
- **Product Code:** [JGJ](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JGJ.md)
- **Decision Date:** Jan 27, 1993
- **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).

---

**Source:** [https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JGJ/K926144](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JGJ/K926144)

**Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact).

**Cite:** Innolitics at https://innolitics.com