DKO · Adsorbents, Ion-Exchange
Clinical Chemistry · 21 CFR 862.2230 · Class 1
Overview
| Product Code | DKO |
|---|---|
| Device Name | Adsorbents, Ion-Exchange |
| Regulation | 21 CFR 862.2230 |
| Device Class | Class 1 |
| Review Panel | Clinical Chemistry |
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.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.
Recent Cleared Devices (1 of 1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K873932 | THE EXTRACTOR(TM) | Molecular Biosystems, Inc. | Nov 20, 1987 | SESE |
Top Applicants
- Molecular Biosystems, Inc. — 1 clearance
