← Product Code [KLS](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/KLS) · K935373

# AXSYM THEOPHYLLINE (K935373)

_Abbott Laboratories · KLS · Jun 21, 1994 · Clinical Toxicology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/KLS/K935373

## Device Facts

- **Applicant:** Abbott Laboratories
- **Product Code:** [KLS](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/KLS.md)
- **Decision Date:** Jun 21, 1994
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 862.3880
- **Device Class:** Class 2
- **Review Panel:** Clinical Toxicology

## Regulatory Identification

A theophylline test system is a device intended to measure theophylline (a drug used for stimulation of the muscles in the cardiovascular, respiratory, and central nervous systems) in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of theophylline overdose or in monitoring levels of theophylline to ensure appropriate therapy.

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**Source:** [https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/KLS/K935373](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/KLS/K935373)

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