← Product Code [JIH](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/JIH) · K770824

# FLAME PHOTOMETER MOLEL 4600, KDA (K770824)

_American Monitor Corp. · JIH · Jul 15, 1977 · Clinical Toxicology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-d%E2%80%94clinical-toxicology-test-systems/JIH/K770824

## Device Facts

- **Applicant:** American Monitor Corp.
- **Product Code:** [JIH](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/JIH.md)
- **Decision Date:** Jul 15, 1977
- **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/K770824](https://fda.innolitics.com/submissions/CH/subpart-d%E2%80%94clinical-toxicology-test-systems/JIH/K770824)

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