Browse hierarchy: [Clinical Chemistry (CH)](/submissions/CH) → [Subpart B — Clinical Chemistry Test Systems](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems) → [21 CFR 862.1495](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/862.1495) → CFO — Titrimetric, Magnesium

# CFO · Titrimetric, Magnesium

_Clinical Chemistry · 21 CFR 862.1495 · Class 1_

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

## Overview

- **Product Code:** CFO
- **Device Name:** Titrimetric, Magnesium
- **Regulation:** [21 CFR 862.1495](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/862.1495)
- **Device Class:** 1
- **Review Panel:** [Clinical Chemistry](/submissions/CH)
- **3rd-party reviewable:** yes

## 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).

## Classification Rationale

Class I.

## Recent Cleared Devices (0 of 0)

_No cleared devices on record._

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

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