← Product Code [LCY](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LCY) · K891761

# GDS ENZYMATIC THEOPHYLLINE REAGENT (K891761)

_Gds Diagnostics · LCY · May 16, 1989 · Clinical Toxicology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-d%E2%80%94clinical-toxicology-test-systems/LCY/K891761

## Device Facts

- **Applicant:** Gds Diagnostics
- **Product Code:** [LCY](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LCY.md)
- **Decision Date:** May 16, 1989
- **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/LCY/K891761](https://fda.innolitics.com/submissions/CH/subpart-d%E2%80%94clinical-toxicology-test-systems/LCY/K891761)

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