Browse hierarchy: [Clinical Toxicology (TX)](/submissions/TX) → [Subpart D — Clinical Toxicology Test Systems](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems) → [21 CFR 862.3750](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/862.3750) → LAM — High Pressure Liquid Chromatography, Quinine

# LAM · High Pressure Liquid Chromatography, Quinine

_Clinical Toxicology · 21 CFR 862.3750 · Class 1_

**Canonical URL:** https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LAM

## Overview

- **Product Code:** LAM
- **Device Name:** High Pressure Liquid Chromatography, Quinine
- **Regulation:** [21 CFR 862.3750](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/862.3750)
- **Device Class:** 1
- **Review Panel:** [Clinical Toxicology](/submissions/TX)
- **3rd-party reviewable:** yes

## Identification

A quinine test system is a device intended to measure quinine, a fever-reducing and pain-relieving drug intended in the treatment of malaria, in serum and urine. Measurements obtained by this device are used in the diagnosis and treatment of quinine overdose and malaria.

## 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/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LAM](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LAM)

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