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 862.3200](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/862.3200) → DNN — Calibrators, Ethyl Alcohol

# DNN · Calibrators, Ethyl Alcohol

_Clinical Toxicology · 21 CFR 862.3200 · Class 2_

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

## Overview

- **Product Code:** DNN
- **Device Name:** Calibrators, Ethyl Alcohol
- **Regulation:** [21 CFR 862.3200](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/862.3200)
- **Device Class:** 2
- **Review Panel:** [Clinical Toxicology](/submissions/TX)

## Identification

A clinical toxicology calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. A clinical toxicology calibrator can be a mixture of drugs or a specific material for a particular drug (e.g., ethanol, lidocaine, etc.). (See also § 862.2 in this part.)

## Classification Rationale

Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.

## Special Controls

*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.

## Recent Cleared Devices (7 of 7)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K990516](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DNN/K990516.md) | ETHYL ALCOHOL CLINICAL STANDARD SOLUTIONS | Emd Chemicals, Inc. | Mar 31, 1999 | SESE |
| [K973054](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DNN/K973054.md) | ETHYL ALCOHOL CLINICAL STANDARD SOLUTIONS | Emd Chemicals, Inc. | Oct 1, 1997 | SESE |
| [K924733](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DNN/K924733.md) | ETHYL ALCOHOL CALIBRATORS & CONTROL | Diagnostic Reagents, Inc. | Dec 9, 1992 | SESE |
| [K882117](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DNN/K882117.md) | ETHYL ALCOHOL STANDARD | Verichem Laboratories, Inc. | Aug 4, 1988 | SESE |
| [K853532](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DNN/K853532.md) | ALCOHOL CALIBRATORS | Diagnostic Systems | Sep 16, 1985 | SESE |
| [K810466](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DNN/K810466.md) | ETHYL ALCOHOL SERUM CALIBRATOR | Syva Co. | Mar 6, 1981 | SESE |
| [K802620](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DNN/K802620.md) | EMIT-STM ETHYL ALCOHOL URINE CALIBRATOR | Syva Co. | Oct 31, 1980 | SESE |

## Top Applicants

- Emd Chemicals, Inc. — 2 clearances
- Syva Co. — 2 clearances
- Diagnostic Reagents, Inc. — 1 clearance
- Diagnostic Systems — 1 clearance
- Verichem Laboratories, Inc. — 1 clearance

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

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