← Product Code [CIE](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CIE) · K771610

# CARBON DIOXIDE ANALYZER (K771610)

_Corning Medical & Scientific · CIE · Oct 7, 1977 · Clinical Chemistry · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CIE/K771610

## Device Facts

- **Applicant:** Corning Medical & Scientific
- **Product Code:** [CIE](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CIE.md)
- **Decision Date:** Oct 7, 1977
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 862.1160
- **Device Class:** Class 2
- **Review Panel:** Clinical Chemistry

## Regulatory Identification

A bicarbonate/carbon dioxide test system is a device intended to measure bicarbonate/carbon dioxide in plasma, serum, and whole blood. Bicarbonate/carbon dioxide measurements are used in the diagnosis and treatment of numerous potentially serious disorders associated with changes in body acid-base balance.

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**Source:** [https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CIE/K771610](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CIE/K771610)

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