BIO-RAD CLINICAL DATA MANAGEMENT SYSTEM
Device Facts
| Record ID | K942451 |
|---|---|
| Device Name | BIO-RAD CLINICAL DATA MANAGEMENT SYSTEM |
| Applicant | Bio-Rad |
| Product Code | LDM · Clinical Chemistry |
| Decision Date | Nov 10, 1994 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.2260 |
| Device Class | Class 1 |
Regulatory Classification
Identification
A high pressure liquid chromatography system for clinical use is a device intended to separate one or more drugs or compounds from a solution by processing the mixture of compounds (solutes) through a column packed with materials of uniform size (stationary phase) under the influence of a high pressure liquid (mobile phase). Separation of the solutes occurs either by absorption, sieving, partition, or selective affinity.
