← Product Code [JGS](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JGS) · K894914

# MODEL 100 PORTABLE CLINICAL ANALYZER AND TEST PACK (K894914)

_I-Stat Corp. · JGS · Oct 16, 1989 · Clinical Chemistry · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JGS/K894914

## Device Facts

- **Applicant:** I-Stat Corp.
- **Product Code:** [JGS](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JGS.md)
- **Decision Date:** Oct 16, 1989
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 862.1665
- **Device Class:** Class 2
- **Review Panel:** Clinical Chemistry

## Regulatory Identification

A sodium test system is a device intended to measure sodium in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of aldosteronism (excessive secretion of the hormone aldosterone), diabetes insipidus (chronic excretion of large amounts of dilute urine, accompanied by extreme thirst), adrenal hypertension, Addison's disease (caused by destruction of the adrenal glands), dehydration, inappropriate antidiuretic hormone secretion, or other diseases involving electrolyte imbalance.

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**Source:** [https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JGS/K894914](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JGS/K894914)

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