DNH · Resins, Ion-Exchange, Liquid Chromatography
Clinical Chemistry · 21 CFR 862.2260 · Class 1
Overview
| Product Code | DNH |
|---|---|
| Device Name | Resins, Ion-Exchange, Liquid Chromatography |
| Regulation | 21 CFR 862.2260 |
| Device Class | Class 1 |
| Review Panel | Clinical Chemistry |
Identification
A high pressure liquid chromatography system for clinical use is a device intended to separate one or more drugs or compounds from a solution by processing the mixture of compounds (solutes) through a column packed with materials of uniform size (stationary phase) under the influence of a high pressure liquid (mobile phase). Separation of the solutes occurs either by absorption, sieving, partition, or selective affinity.
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 § 862.9.
Recent Cleared Devices (1 of 1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K832199 | HC40/HC75 CATION EXCHANGE RESIN | Hamilton Co. | Aug 16, 1983 | SESE |
Top Applicants
- Hamilton Co. — 1 clearance
