OPUS(R) PLUS ANALYZER
Device Facts
| Record ID | K913295 |
|---|---|
| Device Name | OPUS(R) PLUS ANALYZER |
| Applicant | Pb Diagnostic Systems, Inc. |
| Product Code | JJQ · Clinical Chemistry |
| Decision Date | Sep 11, 1991 |
| 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.
