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 862.3550](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/862.3550) → DMK — Lead, Protoporphyrin, Fluorometric

# DMK · Lead, Protoporphyrin, Fluorometric

_Clinical Toxicology · 21 CFR 862.3550 · Class 2_

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

## Overview

- **Product Code:** DMK
- **Device Name:** Lead, Protoporphyrin, Fluorometric
- **Regulation:** [21 CFR 862.3550](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/862.3550)
- **Device Class:** 2
- **Review Panel:** [Clinical Toxicology](/submissions/TX)

## Identification

A lead test system is a device intended to measure lead, a heavy metal, in blood and urine. Measurements obtained by this device are used in the diagnosis and treatment of lead poisoning.

## Classification Rationale

Class II.

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

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