← Product Code [KLS](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/KLS) · K910697

# IL THEOPHYLLINE ASSAY SYSTEM (K910697)

_Instrumentation Laboratory CO · KLS · Apr 3, 1991 · Clinical Toxicology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-d%E2%80%94clinical-toxicology-test-systems/KLS/K910697

## Device Facts

- **Applicant:** Instrumentation Laboratory CO
- **Product Code:** [KLS](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/KLS.md)
- **Decision Date:** Apr 3, 1991
- **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/CH/subpart-d%E2%80%94clinical-toxicology-test-systems/KLS/K910697](https://fda.innolitics.com/submissions/CH/subpart-d%E2%80%94clinical-toxicology-test-systems/KLS/K910697)

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