← Product Code [JJQ](/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/JJQ) · K830101

# COLORIMETERS SERIES ONE 12 (K830101)

_Innotron of Oregon, Inc. · JJQ · Jan 28, 1983 · Clinical Chemistry · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/JJQ/K830101

## Device Facts

- **Applicant:** Innotron of Oregon, Inc.
- **Product Code:** [JJQ](/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/JJQ.md)
- **Decision Date:** Jan 28, 1983
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 862.2300
- **Device Class:** Class 1
- **Review Panel:** Clinical Chemistry

## Regulatory Identification

A colorimeter, a photometer, or a spectrophotometer for clinical use is an instrument intended to measure radiant energy emitted, transmitted, absorbed, or reflected under controlled conditions. The device may include a monochromator to produce light of a specific wavelength.

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**Source:** [https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/JJQ/K830101](https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/JJQ/K830101)

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