← Product Code [CHJ](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CHJ) · K800683

# REAGENT FOR DETERM. CHLORIDE IN HUMAN/SM (K800683)

_Diagnostic Solutions, Inc. · CHJ · May 28, 1980 · Clinical Chemistry · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CHJ/K800683

## Device Facts

- **Applicant:** Diagnostic Solutions, Inc.
- **Product Code:** [CHJ](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CHJ.md)
- **Decision Date:** May 28, 1980
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 862.1170
- **Device Class:** Class 2
- **Review Panel:** Clinical Chemistry

## Regulatory Identification

A chloride test system is a device intended to measure the level of chloride in plasma, serum, sweat, and urine. Chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis.

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**Source:** [https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CHJ/K800683](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CHJ/K800683)

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