← Product Code [NDW](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/NDW) · K003583

# LITHIUM REGENT MODEL TR66056 / LITHIUM STANDARD TR66901 (K003583)

_Trace America, Inc. · NDW · Jan 17, 2001 · Clinical Toxicology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-d%E2%80%94clinical-toxicology-test-systems/NDW/K003583

## Device Facts

- **Applicant:** Trace America, Inc.
- **Product Code:** [NDW](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/NDW.md)
- **Decision Date:** Jan 17, 2001
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 862.3560
- **Device Class:** Class 2
- **Review Panel:** Clinical Toxicology

## Regulatory Identification

A lithium test system is a device intended to measure lithium (from the drug lithium carbonate) in serum or plasma. Measurements of lithium are used to assure that the proper drug dosage is administered in the treatment of patients with mental disturbances, such as manic-depressive illness (bipolar disorder).

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**Source:** [https://fda.innolitics.com/submissions/CH/subpart-d%E2%80%94clinical-toxicology-test-systems/NDW/K003583](https://fda.innolitics.com/submissions/CH/subpart-d%E2%80%94clinical-toxicology-test-systems/NDW/K003583)

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