← Product Code [JQP](/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/JQP) · K801167

# CENTRIFICHEM SYSTEM 400 (K801167)

_Union Carbide Corp. · JQP · Jun 9, 1980 · Clinical Chemistry · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/JQP/K801167

## Device Facts

- **Applicant:** Union Carbide Corp.
- **Product Code:** [JQP](/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/JQP.md)
- **Decision Date:** Jun 9, 1980
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 862.2100
- **Device Class:** Class 1
- **Review Panel:** Clinical Chemistry

## Regulatory Identification

A calculator/data processing module for clinical use is an electronic device intended to process laboratory data.

---

**Source:** [https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/JQP/K801167](https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/JQP/K801167)

**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