← Product Code [JQT](/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/JQT) · K772325

# DENSITOMETER 18, COMPUTING, AUTO. (K772325)

_Gelman Instrument Co. · JQT · Jan 12, 1978 · Clinical Chemistry · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/JQT/K772325

## Device Facts

- **Applicant:** Gelman Instrument Co.
- **Product Code:** [JQT](/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/JQT.md)
- **Decision Date:** Jan 12, 1978
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 862.2400
- **Device Class:** Class 1
- **Review Panel:** Clinical Chemistry

## Regulatory Identification

A densitometer/scanner (integrating, reflectance, thin-layer chromatography, or radiochromatogram) for clinical use is device intended to measure the concentration of a substance on the surface of a film or other support media by either a photocell measurement of the light transmission through a given area of the medium or, in the case of the radiochromatogram scanner, by measurement of the distribution of a specific radio-active element on a radiochromatogram.

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**Source:** [https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/JQT/K772325](https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/JQT/K772325)

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