KIE · Apparatus, High Pressure Liquid Chromatography
Clinical Chemistry · 21 CFR 862.2260 · Class 1
Overview
| Product Code | KIE |
|---|---|
| Device Name | Apparatus, 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 (20 of 25)
Showing 20 most recent of 25 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K964588 | WATERS 515 HPLC PUMP (515) | Waters Corporation | Nov 29, 1996 | SESE |
| K935666 | PERKIN-ELMER SERIES 200 LIQ CHROMATOGRAPHIC PUMP | The Perkin-Elmer Corp. | Apr 26, 1994 | SESE |
| K924347 | WATERS(TM) 996 PDA | Millipore Corp. | Dec 11, 1992 | SESE |
| K914841 | CHROMATOGRAPHY CLINICAL USE 75JQR | Millipore Corp. | Dec 10, 1991 | SESE |
| K911299 | EQUIPMENT/MATERIAL DECONTAMINATING KIT | Rohm and Haas Co. | Apr 8, 1991 | SESE |
| K862506 | THE WATERS MODEL 990 PHOTODIODE ARRAY DETECTOR | Millipore Corp. | Jul 29, 1986 | SESE |
| K844947 | EMIT ANCILLARY REAGENTS | Syva Co. | Jun 28, 1985 | SESE |
| K844949 | SYVA SAMPLE SEAL | Syva Co. | Feb 15, 1985 | SESE |
| K800556 | DIFFERENTIAL REFRACTIVE INDEX DETECTOR | Hewlett-Packard Co. | Mar 25, 1980 | SESE |
| K800516 | DUPONT INSTRUMENTS MODEL 870 LIQ. CHROM. | E.I. Dupont DE Nemours & Co., Inc. | Mar 19, 1980 | SESE |
| K800289 | LDC SPECTROMONITOR III | Laboratory Data Control | Feb 26, 1980 | SESE |
| K800046 | LDC CHROMATOGRAPHY ACCESSORY MODULE B | Laboratory Data Control | Feb 25, 1980 | SESE |
| K800048 | LDC CONSTAMETRIC III HIGHT PRESS. SOL. | Laboratory Data Control | Jan 29, 1980 | SESE |
| K800047 | LDC UVIII FIXED WAVELENGTH ULTRAVIOLET | Laboratory Data Control | Jan 21, 1980 | SESE |
| K791661 | SYSTEM CONTROLLER 720 SERIES | Waters Assoc., Inc. | Sep 24, 1979 | SESE |
| K790145 | SOLVENT DELIVERY SYSTEM | Waters Assoc., Inc. | Feb 15, 1979 | SESE |
| K782175 | CARTRIDGE HOLDER, RCM 100 | Waters Assoc., Inc. | Feb 15, 1979 | SESE |
| K781915 | DATA MODULE | Waters Assoc., Inc. | Jan 10, 1979 | SESE |
| K781771 | DETECTOR, MODEL 79875A, VARIABLE | Hewlett-Packard Co. | Dec 20, 1978 | SESE |
| K781379 | MODEL 5000, LIQUID CHROMATOGRAPHY | Varian Assoc., Inc. | Sep 14, 1978 | SESE |
Top Applicants
- Hewlett-Packard Co. — 4 clearances
- Laboratory Data Control — 4 clearances
- Waters Assoc., Inc. — 4 clearances
- Millipore Corp. — 3 clearances
- The Perkin-Elmer Corp. — 3 clearances
