← Product Code [JQX](/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/JQX) · K792045

# BIOVATION NEPHELOMETER (K792045)

_Biovation, Inc. · JQX · Oct 30, 1979 · Clinical Chemistry · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/JQX/K792045

## Device Facts

- **Applicant:** Biovation, Inc.
- **Product Code:** [JQX](/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/JQX.md)
- **Decision Date:** Oct 30, 1979
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 862.2700
- **Device Class:** Class 1
- **Review Panel:** Clinical Chemistry

## Regulatory Identification

A nephelometer for clinical use is a device intended to estimate the concentration of particles in a suspension by measuring their light scattering properties (the deflection of light rays by opaque particles in their path). The device is used in conjunction with certain materials to measure the concentration of a variety of analytes.

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**Source:** [https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/JQX/K792045](https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/JQX/K792045)

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