LEQ · Detectors, Electrochemical, Liquid Chromatography
Clinical Chemistry · 21 CFR 862.2260 · Class 1
Overview
| Product Code | LEQ |
|---|---|
| Device Name | Detectors, Electrochemical, 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 (4 of 4)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K962574 | WATERS 474 SCANNING FLOURESCENCE DETECTOR (474) | Waters Corporation | Jul 22, 1996 | SESE |
| K903231 | COULOCHEM II | Esa, Inc. | Sep 27, 1990 | SESE |
| K864729 | NEUROCHEMICAL ANALYZER | Esa, Inc. | Apr 13, 1987 | SESE |
| K801439 | MODEL 5100 ELECTROCHEMICAL DETECTOR | Environmental Sciences Assoc., Inc. | Jul 21, 1980 | SESE |
Top Applicants
- Esa, Inc. — 2 clearances
- Waters Corporation — 1 clearance
- Environmental Sciences Assoc., Inc. — 1 clearance
