THE EXTRACTOR(TM)
Device Facts
| Record ID | K873932 |
|---|---|
| Device Name | THE EXTRACTOR(TM) |
| Applicant | Molecular Biosystems, Inc. |
| Product Code | DKO · Clinical Chemistry |
| Decision Date | Nov 20, 1987 |
| 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.