I.C.L.S. COMPULYZER
Device Facts
| Record ID | K854055 |
|---|---|
| Device Name | I.C.L.S. COMPULYZER |
| Applicant | Integrated Computerized Laboratory Systems, Inc. |
| Product Code | JJG · Clinical Chemistry |
| Decision Date | Nov 19, 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.
