DIGENE DCR-1 LUMINOMETER
Device Facts
| Record ID | K940486 |
|---|---|
| Device Name | DIGENE DCR-1 LUMINOMETER |
| Applicant | Digene Diagnostics, Inc. |
| Product Code | JJQ · Clinical Chemistry |
| Decision Date | Apr 18, 1995 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.2300 |
| Device Class | Class 1 |
Regulatory Classification
Identification
A colorimeter, a photometer, or a spectrophotometer for clinical use is an instrument intended to measure radiant energy emitted, transmitted, absorbed, or reflected under controlled conditions. The device may include a monochromator to produce light of a specific wavelength.
