← Product Code [CHJ](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CHJ) · K850334

# ROCHE REAGENT FOR CHLORIDE, FOR THE COBAS (K850334)

_Roche Diagnostic Systems, Inc. · CHJ · Mar 14, 1985 · Clinical Chemistry · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CHJ/K850334

## Device Facts

- **Applicant:** Roche Diagnostic Systems, Inc.
- **Product Code:** [CHJ](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CHJ.md)
- **Decision Date:** Mar 14, 1985
- **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/K850334](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CHJ/K850334)

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