← Product Code [CHJ](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CHJ) · K770752

# REAGENT, CHLORIDE, COULTER (K770752)

_Coulter Electronics, Inc. · CHJ · Jun 17, 1977 · Clinical Chemistry · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CHJ/K770752

## Device Facts

- **Applicant:** Coulter Electronics, Inc.
- **Product Code:** [CHJ](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CHJ.md)
- **Decision Date:** Jun 17, 1977
- **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/K770752](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CHJ/K770752)

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