← Product Code [DLZ](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DLZ) · K942501

# ACE CEDIA PHENOBARBITAL ASSAY (K942501)

_Schiapparelli Biosystems, Inc. · DLZ · Oct 6, 1994 · Clinical Toxicology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-d%E2%80%94clinical-toxicology-test-systems/DLZ/K942501

## Device Facts

- **Applicant:** Schiapparelli Biosystems, Inc.
- **Product Code:** [DLZ](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DLZ.md)
- **Decision Date:** Oct 6, 1994
- **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/CH/subpart-d%E2%80%94clinical-toxicology-test-systems/DLZ/K942501](https://fda.innolitics.com/submissions/CH/subpart-d%E2%80%94clinical-toxicology-test-systems/DLZ/K942501)

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