← Product Code [JJO](/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/JJO) · K823480

# IL 943 FLAME PHOTOMETER (K823480)

_Instrumentation Laboratory CO · JJO · Jan 9, 1983 · Clinical Chemistry · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/JJO/K823480

## Device Facts

- **Applicant:** Instrumentation Laboratory CO
- **Product Code:** [JJO](/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/JJO.md)
- **Decision Date:** Jan 9, 1983
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 862.2540
- **Device Class:** Class 1
- **Review Panel:** Clinical Chemistry

## Regulatory Identification

A flame emission photometer for clinical use is a device intended to measure the concentration of sodium, potassium, lithium, and other metal ions in body fluids. Abnormal variations in the concentration of these substances in the body are indicative of certain disorders (e.g., electrolyte imbalance and heavy metal intoxication) and are, therefore, useful in diagnosis and treatment of those disorders.

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**Source:** [https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/JJO/K823480](https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/JJO/K823480)

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