← Product Code [JJO](/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/JJO) · K833535

# POTASSIUM SODIUM ANALYSIS PRODUCTS (K833535)

_Shaban Mfg. Co. · JJO · Dec 29, 1983 · Clinical Chemistry · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/JJO/K833535

## Device Facts

- **Applicant:** Shaban Mfg. Co.
- **Product Code:** [JJO](/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/JJO.md)
- **Decision Date:** Dec 29, 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/K833535](https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/JJO/K833535)

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