← Product Code [KLS](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/KLS) · K011166

# MODIFICATION TO EMIT 2000 THEOPHYLLINE ASSAY, MODEL OSR 4P229 (K011166)

_Syva Co., Dade Behring, Inc. · KLS · May 10, 2001 · Clinical Toxicology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-d%E2%80%94clinical-toxicology-test-systems/KLS/K011166

## Device Facts

- **Applicant:** Syva Co., Dade Behring, Inc.
- **Product Code:** [KLS](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/KLS.md)
- **Decision Date:** May 10, 2001
- **Decision:** SESE
- **Submission Type:** Special
- **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/K011166](https://fda.innolitics.com/submissions/CH/subpart-d%E2%80%94clinical-toxicology-test-systems/KLS/K011166)

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