← Product Code [KLR](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/KLR) · K833623

# MODIF. OF EMIT CAD DISOPYRAMIDE ASSAY (K833623)

_Syva Co. · KLR · Dec 8, 1983 · Clinical Toxicology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/KLR/K833623

## Device Facts

- **Applicant:** Syva Co.
- **Product Code:** [KLR](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/KLR.md)
- **Decision Date:** Dec 8, 1983
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 862.3555
- **Device Class:** Class 2
- **Review Panel:** Clinical Toxicology

## Regulatory Identification

A lidocaine test system is a device intended to measure lidocaine, an antiarrythmic and anticonvulsant drug, in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of lidocaine overdose or in monitoring levels of lidocaine to ensure appropriate therapy.

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**Source:** [https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/KLR/K833623](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/KLR/K833623)

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