VITROS IMMUNODIAGNOSTIC SYSTEM
Device Facts
| Record ID | K962919 |
|---|---|
| Device Name | VITROS IMMUNODIAGNOSTIC SYSTEM |
| Applicant | Johnson & Johnson Clinical Diagnostics, Inc. |
| Product Code | KHO · Clinical Chemistry |
| Decision Date | Oct 18, 1996 |
| 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.
