← Product Code [DKP](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DKP) · K844167

# ARIA HT PHENOBARBITAL RADIOIMMUNOASSAY KIT (K844167)

_Bd Becton Dickinson Vacutainer Systems Preanalytic · DKP · Nov 27, 1984 · Clinical Toxicology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DKP/K844167

## Device Facts

- **Applicant:** Bd Becton Dickinson Vacutainer Systems Preanalytic
- **Product Code:** [DKP](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DKP.md)
- **Decision Date:** Nov 27, 1984
- **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/DKP/K844167](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DKP/K844167)

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