← Product Code [JIH](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/JIH) · K800039

# LITHIUM DILUENT (1500 MM/E) (K800039)

_Gilford Diagnostics · JIH · Jan 21, 1980 · Clinical Toxicology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-d%E2%80%94clinical-toxicology-test-systems/JIH/K800039

## Device Facts

- **Applicant:** Gilford Diagnostics
- **Product Code:** [JIH](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/JIH.md)
- **Decision Date:** Jan 21, 1980
- **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/K800039](https://fda.innolitics.com/submissions/CH/subpart-d%E2%80%94clinical-toxicology-test-systems/JIH/K800039)

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