DMG · Papers, Ion
Clinical Chemistry · 21 CFR 862.2230 · Class 1
Overview
| Product Code | DMG |
|---|---|
| Device Name | Papers, Ion |
| 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 (0 of 0)
No cleared devices on record.
