← Product Code [LGS](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LGS) · K900706

# MODIFIED ACCUFLUOR THEOPHYLLINE REAGENT & CALIBRA (K900706)

_Innotron of Oregon, Inc. · LGS · Apr 12, 1990 · Clinical Toxicology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LGS/K900706

## Device Facts

- **Applicant:** Innotron of Oregon, Inc.
- **Product Code:** [LGS](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LGS.md)
- **Decision Date:** Apr 12, 1990
- **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/LGS/K900706](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LGS/K900706)

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