← Product Code [JIH](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/JIH) · K921403

# MODEL 654 ANALYZER (K921403)

_Ciba Corning Diagnostics Corp. · JIH · Jul 30, 1992 · Clinical Toxicology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-d%E2%80%94clinical-toxicology-test-systems/JIH/K921403

## Device Facts

- **Applicant:** Ciba Corning Diagnostics Corp.
- **Product Code:** [JIH](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/JIH.md)
- **Decision Date:** Jul 30, 1992
- **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/K921403](https://fda.innolitics.com/submissions/CH/subpart-d%E2%80%94clinical-toxicology-test-systems/JIH/K921403)

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