← Product Code [JJH](/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/JJH) · K770398

# MINICON (K770398)

_Amicon, Inc. · JJH · Apr 6, 1977 · Clinical Chemistry · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/IM/subpart-c%E2%80%94clinical-laboratory-instruments/JJH/K770398

## Device Facts

- **Applicant:** Amicon, Inc.
- **Product Code:** [JJH](/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/JJH.md)
- **Decision Date:** Apr 6, 1977
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 862.2310
- **Device Class:** Class 1
- **Review Panel:** Clinical Chemistry

## Regulatory Identification

A clinical sample concentrator is a device intended to concentrate (by dialysis, evaporation, etc.) serum, urine, cerebrospinal fluid, and other body fluids before the fluids are analyzed.

---

**Source:** [https://fda.innolitics.com/submissions/IM/subpart-c%E2%80%94clinical-laboratory-instruments/JJH/K770398](https://fda.innolitics.com/submissions/IM/subpart-c%E2%80%94clinical-laboratory-instruments/JJH/K770398)

**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