← Product Code [LET](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LET) · K901537

# MODIFIED OPUS PHENOBARBITAL TEST SYSTEM (K901537)

_Pb Diagnostic Systems, Inc. · LET · Jun 12, 1990 · Clinical Toxicology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LET/K901537

## Device Facts

- **Applicant:** Pb Diagnostic Systems, Inc.
- **Product Code:** [LET](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LET.md)
- **Decision Date:** Jun 12, 1990
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 862.3660
- **Device Class:** Class 2
- **Review Panel:** Clinical Toxicology

## Regulatory Identification

A phenobarbitol test system is a device intended to measure phenobarbital, an antiepileptic and sedative-hypnotic drug, in human specimens. Measurements obtained by this device are used in the diagnosis and treatment of phenobarbital use or overdose and in monitoring levels of phenobarbital to ensure appropriate therapy.

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**Source:** [https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LET/K901537](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LET/K901537)

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