← Product Code [JIH](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/JIH) · K011033

# DIMENSION LITHIUM (LI) FLEX REAGENT CARTRIDGE, MODEL DF 132 (K011033)

_Dade Behring, Inc. · JIH · Jun 7, 2001 · Clinical Toxicology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-d%E2%80%94clinical-toxicology-test-systems/JIH/K011033

## Device Facts

- **Applicant:** Dade Behring, Inc.
- **Product Code:** [JIH](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/JIH.md)
- **Decision Date:** Jun 7, 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/JIH/K011033](https://fda.innolitics.com/submissions/CH/subpart-d%E2%80%94clinical-toxicology-test-systems/JIH/K011033)

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