← Product Code [LGQ](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LGQ) · K936130

# COBAS-FP REAGENT FOR PHENOBARBITAL AND COBAS-FP PHENOBARBITAL CALIBRATORS (K936130)

_Roche Diagnostic Systems, Inc. · LGQ · Mar 11, 1994 · Clinical Toxicology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LGQ/K936130

## Device Facts

- **Applicant:** Roche Diagnostic Systems, Inc.
- **Product Code:** [LGQ](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LGQ.md)
- **Decision Date:** Mar 11, 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/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LGQ/K936130](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LGQ/K936130)

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