← Product Code [KLR](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/KLR) · K843184

# STRATUS LIDOCAINE FLUOROMETRIC ENZYME (K843184)

_American Dade · KLR · Sep 26, 1984 · Clinical Toxicology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/IM/subpart-d%E2%80%94clinical-toxicology-test-systems/KLR/K843184

## Device Facts

- **Applicant:** American Dade
- **Product Code:** [KLR](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/KLR.md)
- **Decision Date:** Sep 26, 1984
- **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/IM/subpart-d%E2%80%94clinical-toxicology-test-systems/KLR/K843184](https://fda.innolitics.com/submissions/IM/subpart-d%E2%80%94clinical-toxicology-test-systems/KLR/K843184)

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