← Product Code [LGQ](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LGQ) · K872397

# COBAS FP REAGENTS FOR PHENO & COBAS FP PHENO CALI. (K872397)

_Roche Diagnostic Systems, Inc. · LGQ · Jul 21, 1987 · Clinical Toxicology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LGQ/K872397

## Device Facts

- **Applicant:** Roche Diagnostic Systems, Inc.
- **Product Code:** [LGQ](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LGQ.md)
- **Decision Date:** Jul 21, 1987
- **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.

---

**Source:** [https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LGQ/K872397](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LGQ/K872397)

**Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact).

**Cite:** Innolitics at https://innolitics.com