← Product Code [JFL](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JFL) · K873129

# CARBON DIOXIDE REAGENT KIT (K873129)

_A-Kem, Inc. · JFL · Oct 23, 1987 · Clinical Chemistry · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JFL/K873129

## Device Facts

- **Applicant:** A-Kem, Inc.
- **Product Code:** [JFL](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JFL.md)
- **Decision Date:** Oct 23, 1987
- **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/JFL/K873129](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JFL/K873129)

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