← Product Code [JJC](/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/JJC) · K801481

# BMC RIAFLO SYSTEM (K801481)

_Boehringer Mannheim Corp. · JJC · Aug 20, 1980 · Clinical Chemistry · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/JJC/K801481

## Device Facts

- **Applicant:** Boehringer Mannheim Corp.
- **Product Code:** [JJC](/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/JJC.md)
- **Decision Date:** Aug 20, 1980
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 862.2150
- **Device Class:** Class 1
- **Review Panel:** Clinical Chemistry

## Regulatory Identification

A continuous flow sequential multiple chemistry analyzer for clinical use is a modular analytical instrument intended to simultaneously perform multiple chemical procedures using the principles of automated continuous flow systems. This device is intended for use in conjunction with certain materials to measure a variety of analytes.

---

**Source:** [https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/JJC/K801481](https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/JJC/K801481)

**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
