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 862.3040](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/862.3040) → DOJ — Potassium Dichromate, Alcohol

# DOJ · Potassium Dichromate, Alcohol

_Clinical Toxicology · 21 CFR 862.3040 · Class 2_

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

## Overview

- **Product Code:** DOJ
- **Device Name:** Potassium Dichromate, Alcohol
- **Regulation:** [21 CFR 862.3040](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/862.3040)
- **Device Class:** 2
- **Review Panel:** [Clinical Toxicology](/submissions/TX)
- **3rd-party reviewable:** yes

## Identification

An alcohol test system is a device intented to measure alcohol (e.g., ethanol, methanol, isopropanol, etc.) in human body fluids (e.g., serum, whole blood, and urine). Measurements obtained by this device are used in the diagnosis and treatment of alcohol intoxication and poisoning.

## Classification Rationale

Class II.

## Recent Cleared Devices (2 of 2)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K903223](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DOJ/K903223.md) | ON-SITE ALCOHOL | Toxi-Lab, Inc. | Mar 13, 1991 | SESE |
| [K792469](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DOJ/K792469.md) | INTERSCI TEST FOR ALCOHOL IN BODY FLUIDS | Intersci Corp. | Jan 23, 1980 | SESE |

## Top Applicants

- Intersci Corp. — 1 clearance
- Toxi-Lab, Inc. — 1 clearance

---

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

**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