← Product Code [JRE](/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/JRE) · K941902

# MODEL 3471 CLINICAL REFRACTOMETER (K941902)

_Vee Gee Scientific, Inc. · JRE · Dec 13, 1994 · Clinical Chemistry · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/JRE/K941902

## Device Facts

- **Applicant:** Vee Gee Scientific, Inc.
- **Product Code:** [JRE](/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/JRE.md)
- **Decision Date:** Dec 13, 1994
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 862.2800
- **Device Class:** Class 1
- **Review Panel:** Clinical Chemistry

## Regulatory Identification

A refractometer for clinical use is a device intended to determine the amount of solute in a solution by measuring the index of refraction (the ratio of the velocity of light in a vacuum to the velocity of light in the solution). The index of refraction is used to measure the concentration of certain analytes (solutes), such a plasma total proteins and urinary total solids. Measurements obtained by this device are used in the diagnosis and treatment of certain conditions.

---

**Source:** [https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/JRE/K941902](https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/JRE/K941902)

**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