JQT · Densitometer/Scanner (Integrating, Reflectance, Tlc, Radiochromat.) Clinica
Clinical Chemistry · 21 CFR 862.2400 · Class 1
Overview
| Product Code | JQT |
|---|---|
| Device Name | Densitometer/Scanner (Integrating, Reflectance, Tlc, Radiochromat.) Clinica |
| Regulation | 21 CFR 862.2400 |
| Device Class | Class 1 |
| Review Panel | Clinical Chemistry |
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 | ASIMANAGER - AT | Arlington Scientific, Inc. | Nov 9, 2011 | SESE |
| K944185 | ISOSCAN | Isolab, Inc. | Nov 17, 1994 | SESE |
| K915332 | MODEL 795 FLUOROMETER/DENSITOMETER | Ciba Corning Diagnostics Corp. | Feb 18, 1992 | SESE |
| K885254 | TARGET READER | V-Tech, Inc. | Jan 27, 1989 | SESE |
| K860645 | ELECTROPHORESIS DATA CENTER (EDC) | Helena Laboratories | Dec 17, 1986 | SESE |
| K862956 | ICON READER | Hybritech, Inc. | Aug 19, 1986 | SESE |
| K853734 | APOLLO DENSITOMETER | Astral Medical Systems | Sep 25, 1985 | SESE |
| K851154 | ELECTROPHORESIS APPARATUS, FOR CLINICAL USE 160,18 | Astral Medical Systems | May 13, 1985 | SESE |
| K850617 | CORNING 780 FLUOROMETER/DENSITOMETER | Corning Medical & Scientific | Mar 12, 1985 | SESE |
| K850260 | GLEMAN ACD-2020 AUTOMATIC COMPUTING DENSITOMETER | Gelman Sciences, Inc. | Feb 27, 1985 | SESE |
| K842313 | ELVI 146 SEROSCAN | Logos Scientific, Inc. | Sep 10, 1984 | SESE |
| K842056 | ELVI 165 PROTEO SEROSKOP | Logos Scientific, Inc. | Jun 22, 1984 | SESE |
| K810619 | 710 FLUOROMETER/DENSITOMETER | Corning Medical & Scientific | Mar 27, 1981 | SESE |
| K803240 | CORNING 760 FLUOROMETER/DENSITOMETER | Transidyne General Corp. | Jan 9, 1981 | SESE |
| K780901 | AUTOMATED ELECTROPHORESIS SYSTEM | Olympus Corp. | Jun 28, 1978 | SESE |
| K780318 | MODULAR SCANNING DENSITOMETER SYS. | Transidyne General Corp. | Apr 12, 1978 | SESE |
| K772325 | DENSITOMETER 18, COMPUTING, AUTO. | Gelman Instrument Co. | Jan 12, 1978 | SESE |
| K770026 | 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
