FLUORESCENCE DETECTOR MODEL 420
Device Facts
| Record ID | K780031 |
|---|---|
| Device Name | FLUORESCENCE DETECTOR MODEL 420 |
| Applicant | Waters Assoc., Inc. |
| Product Code | KHO · Clinical Chemistry |
| Decision Date | Jan 20, 1978 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.2560 |
| Device Class | Class 1 |
Regulatory Classification
Identification
A fluorometer for clinical use is a device intended to measure by fluorescence certain analytes. Fluorescence is the property of certain substances of radiating, when illuminated, a light of a different wavelength. This device is used in conjunction with certain materials to measure a variety of analytes.
