DJA · Column Supports, Glc
Clinical Chemistry · 21 CFR 862.2250 · Class 1
Overview
| Product Code | DJA |
|---|---|
| Device Name | Column Supports, Glc |
| Regulation | 21 CFR 862.2250 |
| Device Class | Class 1 |
| Review Panel | Clinical Chemistry |
Identification
A gas liquid chromatography system for clinical use is a device intended to separate one or more drugs or compounds from a mixture. Each of the constituents in a vaporized mixture of compounds is separated according to its vapor pressure. The device may include accessories such as columns, gases, column supports, and liquid coating.
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 |
|---|---|---|---|---|
| K801833 | GAS-CHROMATOGRAPHIC PACKING | Supelco, Inc. | Aug 27, 1980 | SESE |
Top Applicants
- Supelco, Inc. — 1 clearance
