DLG · Coating, Liquid, Glc
Clinical Chemistry · 21 CFR 862.2250 · Class 1
Overview
| Product Code | DLG |
|---|---|
| Device Name | Coating, Liquid, 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 (7 of 7)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K050988 | OPIATE ORAL FLUID HOMOGENEOUS ENZYME IMMUNOASSAY, CALIBRATORS AND CONTROLS | Lin-Zhi International, Inc. | Apr 6, 2006 | SESE |
| K920419 | IL TEST DAT CAL/CONTROL SET D/E | Instrumentation Laboratory CO | Mar 11, 1992 | SESE |
| K894524 | FPR GENTAMICIN CALIBRATOR KIT | Colony Laboratories, Inc. | Sep 28, 1989 | SESE |
| K894518 | FPR AMIKACIN CALIBRATOR KIT | Colony Laboratories, Inc. | Sep 28, 1989 | SESE |
| K894528 | FPR PHENYTOIN CALIBRATOR KIT | Colony Laboratories, Inc. | Sep 25, 1989 | SESE |
| K882766 | EMDS ACETAMINOPHEN CALIBRATOR NO. 67636/95 | Em Diagnostic Systems, Inc. | Aug 23, 1988 | SESE |
| K833385 | N-ACETYLPROCAINAMIDE CALIBRATOR | E.I. Dupont DE Nemours & Co., Inc. | Dec 16, 1983 | SESE |
Top Applicants
- Colony Laboratories, Inc. — 3 clearances
- Lin-Zhi International, Inc. — 1 clearance
- Instrumentation Laboratory CO — 1 clearance
- Em Diagnostic Systems, Inc. — 1 clearance
- E.I. Dupont DE Nemours & Co., Inc. — 1 clearance
