Browse hierarchy: [Clinical Chemistry (CH)](/submissions/CH) → [Subpart C — Clinical Laboratory Instruments](/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments) → [21 CFR 862.2400](/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/862.2400) → JQT — Densitometer/Scanner (Integrating, Reflectance, Tlc, Radiochromat.) Clinica

# JQT · Densitometer/Scanner (Integrating, Reflectance, Tlc, Radiochromat.) Clinica

_Clinical Chemistry · 21 CFR 862.2400 · Class 1_

**Canonical URL:** https://fda.innolitics.com/productcode/JQT

## Overview

- **Product Code:** JQT
- **Device Name:** Densitometer/Scanner (Integrating, Reflectance, Tlc, Radiochromat.) Clinica
- **Regulation:** [21 CFR 862.2400](/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/862.2400)
- **Device Class:** 1
- **Review Panel:** [Clinical Chemistry](/submissions/CH)

## 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.

## Classification Rationale

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.

## Recent Cleared Devices (18 of 18)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K111356](/device/K111356.md) | ASIMANAGER - AT | Arlington Scientific, Inc. | Nov 9, 2011 | SESE |
| [K944185](/device/K944185.md) | ISOSCAN | Isolab, Inc. | Nov 17, 1994 | SESE |
| [K915332](/device/K915332.md) | MODEL 795 FLUOROMETER/DENSITOMETER | Ciba Corning Diagnostics Corp. | Feb 18, 1992 | SESE |
| [K885254](/device/K885254.md) | TARGET READER | V-Tech, Inc. | Jan 27, 1989 | SESE |
| [K860645](/device/K860645.md) | ELECTROPHORESIS DATA CENTER (EDC) | Helena Laboratories | Dec 17, 1986 | SESE |
| [K862956](/device/K862956.md) | ICON READER | Hybritech, Inc. | Aug 19, 1986 | SESE |
| [K853734](/device/K853734.md) | APOLLO DENSITOMETER | Astral Medical Systems | Sep 25, 1985 | SESE |
| [K851154](/device/K851154.md) | ELECTROPHORESIS APPARATUS, FOR CLINICAL USE 160,18 | Astral Medical Systems | May 13, 1985 | SESE |
| [K850617](/device/K850617.md) | CORNING 780 FLUOROMETER/DENSITOMETER | Corning Medical & Scientific | Mar 12, 1985 | SESE |
| [K850260](/device/K850260.md) | GLEMAN ACD-2020 AUTOMATIC COMPUTING DENSITOMETER | Gelman Sciences, Inc. | Feb 27, 1985 | SESE |
| [K842313](/device/K842313.md) | ELVI 146 SEROSCAN | Logos Scientific, Inc. | Sep 10, 1984 | SESE |
| [K842056](/device/K842056.md) | ELVI 165 PROTEO SEROSKOP | Logos Scientific, Inc. | Jun 22, 1984 | SESE |
| [K810619](/device/K810619.md) | 710 FLUOROMETER/DENSITOMETER | Corning Medical & Scientific | Mar 27, 1981 | SESE |
| [K803240](/device/K803240.md) | CORNING 760 FLUOROMETER/DENSITOMETER | Transidyne General Corp. | Jan 9, 1981 | SESE |
| [K780901](/device/K780901.md) | AUTOMATED ELECTROPHORESIS SYSTEM | Olympus Corp. | Jun 28, 1978 | SESE |
| [K780318](/device/K780318.md) | MODULAR SCANNING DENSITOMETER SYS. | Transidyne General Corp. | Apr 12, 1978 | SESE |
| [K772325](/device/K772325.md) | DENSITOMETER 18, COMPUTING, AUTO. | Gelman Instrument Co. | Jan 12, 1978 | SESE |
| [K770026](/device/K770026.md) | FLOUROMETER/DENSITOMETER MODEL 720 | Corning Medical & Scientific | Jan 26, 1977 | SESE |

## Top Applicants

- Corning Medical & Scientific — 3 clearances
- Astral Medical Systems — 2 clearances
- Logos Scientific, Inc. — 2 clearances
- Transidyne General Corp. — 2 clearances
- Arlington Scientific, Inc. — 1 clearance

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**Source:** [https://fda.innolitics.com/productcode/JQT](https://fda.innolitics.com/productcode/JQT)

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