← Product Code [DIP](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DIP) · K944085

# ACE(TM) CEDIA(R) PHENYTOIN ASSAY (K944085)

_Schiapparelli Biosystems, Inc. · DIP · Dec 28, 1994 · Clinical Toxicology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-d%E2%80%94clinical-toxicology-test-systems/DIP/K944085

## Device Facts

- **Applicant:** Schiapparelli Biosystems, Inc.
- **Product Code:** [DIP](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DIP.md)
- **Decision Date:** Dec 28, 1994
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 862.3350
- **Device Class:** Class 2
- **Review Panel:** Clinical Toxicology

## Regulatory Identification

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

---

**Source:** [https://fda.innolitics.com/submissions/CH/subpart-d%E2%80%94clinical-toxicology-test-systems/DIP/K944085](https://fda.innolitics.com/submissions/CH/subpart-d%E2%80%94clinical-toxicology-test-systems/DIP/K944085)

**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