I.E.C COLUMN
Device Facts
| Record ID | K830918 |
|---|---|
| Device Name | I.E.C COLUMN |
| Applicant | Berwick Medical Products, Inc. |
| Product Code | KEA · Clinical Chemistry |
| Decision Date | Apr 27, 1983 |
| 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.
