LDM · Instrumentation, High Pressure Liquid Chromatography
Clinical Chemistry · 21 CFR 862.2260 · Class 1
Overview
| Product Code | LDM |
|---|---|
| Device Name | Instrumentation, High Pressure 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 (19 of 19)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K960392 | CDM | Bio-Rad | Jul 8, 1996 | SESE |
| K961557 | ALLIANCE 2690 SEPARATIONS MODULE | Waters Corporation | Jul 5, 1996 | SESE |
| K942451 | BIO-RAD CLINICAL DATA MANAGEMENT SYSTEM | Bio-Rad | Nov 10, 1994 | SESE |
| K922388 | WATERS(TM) LC MODULE I FOR CLINICAL USE | Millipore Corp. | Sep 11, 1992 | SESE |
| K920136 | WATERS 717 AUTOSAMPLER | Millipore Corp. | Feb 19, 1992 | SESE |
| K903647 | MODULE 486 VARIABLE WAVELENGTH TUNABLE UV/VIS DETE | Millipore Corp. | Sep 11, 1990 | SESE |
| K884886 | MODEL 250 LIQUID CHROMOTAGRAPHY PUMP | The Perkin-Elmer Corp. | Feb 2, 1989 | SESE |
| K872582 | HIGH PRESSURE LIQUID CHROMATOGRAPHY SYSTEM | Millipore Corp. | Jul 16, 1987 | SESE |
| K870949 | WATERS 650 ADVANCED PROTEIN PURIFICATION SYSTEM | Millipore Corp. | Apr 22, 1987 | SESE |
| K862178 | ISOPURE LC SYSTEM | The Perkin-Elmer Corp. | Jul 14, 1986 | SESE |
| K850272 | WATERS 740 DATA MODULE-PLOTTER INTEGRATOR | Millipore Corp. | Mar 6, 1985 | SESE |
| K850359 | WATERS 460 LIQUID CHROMATOGRAPHY ELECTROCHEMICAL D | Millipore Corp. | Mar 5, 1985 | SESE |
| K833113 | REPORTING INTEGRATOR 3392A | Hewlett-Packard Co. | Nov 21, 1983 | SESE |
| K832375 | LIQUID CHROMATOGRAPH 1090 SERIES | Hewlett-Packard Co. | Oct 14, 1983 | SESE |
| K821727 | SERIES 10 LIQUID CHROMOTOGRAPH | The Perkin-Elmer Corp. | Jun 22, 1982 | SESE |
| K821219 | SERIES 4 LIQUID CHROMATOGRAPH | The Perkin-Elmer Corp. | May 28, 1982 | SESE |
| K810304 | MODEL LC-85 UV DETECTOR | The Perkin-Elmer Corp. | Feb 25, 1981 | SESE |
| K802031 | 3390A REPORTING INTEGRATOR | Hewlett-Packard Co. | Sep 16, 1980 | SESE |
| K780933 | PREP I AUTOMATED SAMPLE PROCESSOR | E.I. Dupont DE Nemours & Co., Inc. | Jul 27, 1978 | SESE |
Top Applicants
- Millipore Corp. — 7 clearances
- The Perkin-Elmer Corp. — 5 clearances
- Hewlett-Packard Co. — 3 clearances
- Bio-Rad — 2 clearances
- Waters Corporation — 1 clearance
