GEN PROFILER SYSTEM
Device Facts
| Record ID | K851619 |
|---|---|
| Device Name | GEN PROFILER SYSTEM |
| Applicant | Electro-Cucleonics, Inc. |
| Product Code | JJG · Clinical Chemistry |
| Decision Date | May 14, 1985 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.2140 |
| Device Class | Class 1 |
Regulatory Classification
Identification
A centrifugal chemistry analyzer for clinical use is an automatic device intended to centrifugally mix a sample and a reagent and spectrophotometrically measure concentrations of the sample constituents. This device is intended for use in conjunction with certain materials to measure a variety of analytes.
