← Product Code [KHS](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/KHS) · K880609

# ANALYTE CARBON DIOXIDE ASSAYED ON TECHNICON RA(TM) (K880609)

_Technicon Instruments Corp. · KHS · Mar 16, 1988 · Clinical Chemistry · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/KHS/K880609

## Device Facts

- **Applicant:** Technicon Instruments Corp.
- **Product Code:** [KHS](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/KHS.md)
- **Decision Date:** Mar 16, 1988
- **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/KHS/K880609](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/KHS/K880609)

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