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 862.3600](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/862.3600) → DPH — Mercury, Atomic Absorption

# DPH · Mercury, Atomic Absorption

_Clinical Toxicology · 21 CFR 862.3600 · Class 1_

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

## Overview

- **Product Code:** DPH
- **Device Name:** Mercury, Atomic Absorption
- **Regulation:** [21 CFR 862.3600](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/862.3600)
- **Device Class:** 1
- **Review Panel:** [Clinical Toxicology](/submissions/TX)
- **3rd-party reviewable:** yes

## Identification

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

## Classification Rationale

Class I.

## Recent Cleared Devices (2 of 2)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K832933](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DPH/K832933.md) | GOLD FILM MERCURY ANALYZER #511 | Jerome Instrument Corp. | Nov 25, 1983 | SESE |
| [K781010](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DPH/K781010.md) | MERCURY/HYDRIDE ATOMIC ABSORPTION ACCESS | The Perkin-Elmer Corp. | Jul 27, 1978 | SESE |

## Top Applicants

- Jerome Instrument Corp. — 1 clearance
- The Perkin-Elmer Corp. — 1 clearance

---

**Source:** [https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DPH](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DPH)

**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
