MODEL 795 FLUOROMETER/DENSITOMETER
Device Facts
| Record ID | K915332 |
|---|---|
| Device Name | MODEL 795 FLUOROMETER/DENSITOMETER |
| Applicant | Ciba Corning Diagnostics Corp. |
| Product Code | JQT · Clinical Chemistry |
| Decision Date | Feb 18, 1992 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.2400 |
| Device Class | Class 1 |
Regulatory Classification
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.
