DII · Columns, Glc
Clinical Chemistry · 21 CFR 862.2250 · Class 1
Overview
| Product Code | DII |
|---|---|
| Device Name | Columns, 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 (5 of 5)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K874824 | CAPILLARY COLUMNS FOR GAS CHROMATOGRAPHY | Supelco, Inc. | Jan 21, 1988 | SESE |
| K862542 | CAPILLARY COLUMNS FOR GAS CHROMATOGRAPHY | Supelco, Inc. | Aug 4, 1986 | SESE |
| K844164 | REACTIFS, IBF ULTROGELS ACA & ULTROGELS A | Lkb Instruments, Inc. | Dec 10, 1984 | SESE |
| K841712 | CAPILLARY GAS CHROMATOGRAPHIC COLUMNS | Supelco, Inc. | May 21, 1984 | SESE |
| K791893 | 19091-XXXXX SER. OF GLASS CAPILLARY COL. | Hewlett-Packard Co. | Oct 30, 1979 | SESE |
Top Applicants
- Supelco, Inc. — 3 clearances
- Hewlett-Packard Co. — 1 clearance
- Lkb Instruments, Inc. — 1 clearance
