SYVA SOLID PHASE COLUMNS
Device Facts
| Record ID | K844948 |
|---|---|
| Device Name | SYVA SOLID PHASE COLUMNS |
| Applicant | Syva Co. |
| Product Code | KEA · Clinical Chemistry |
| Decision Date | Aug 29, 1985 |
| 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.