THE CDI(R) SYSTEM 400
Device Facts
| Record ID | K890113 |
|---|---|
| Device Name | THE CDI(R) SYSTEM 400 |
| Applicant | Cardiovascular Devices, Inc. |
| Product Code | DJY · Clinical Chemistry |
| Decision Date | May 23, 1989 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.2230 |
| Device Class | Class 1 |
Regulatory Classification
Identification
A chromatographic separation material for clinical use is a device accessory (e.g., ion exchange absorbents, ion exchagne resins, and ion papers) intended for use in ion exchange chromatography, a procedure in which a compound is separated from a solution.
