Browse hierarchy: [Clinical Chemistry (CH)](/submissions/CH) → [Subpart C — Clinical Laboratory Instruments](/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments) → [21 CFR 862.2260](/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/862.2260) → KIE — Apparatus, High Pressure Liquid Chromatography # KIE · Apparatus, High Pressure Liquid Chromatography _Clinical Chemistry · 21 CFR 862.2260 · Class 1_ **Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/KIE ## Overview - **Product Code:** KIE - **Device Name:** Apparatus, High Pressure Liquid Chromatography - **Regulation:** [21 CFR 862.2260](/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/862.2260) - **Device Class:** 1 - **Review Panel:** [Clinical Chemistry](/submissions/CH) ## 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](https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/KIE/K964588.md) | WATERS 515 HPLC PUMP (515) | Waters Corporation | Nov 29, 1996 | SESE | | [K935666](https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/KIE/K935666.md) | PERKIN-ELMER SERIES 200 LIQ CHROMATOGRAPHIC PUMP | The Perkin-Elmer Corp. | Apr 26, 1994 | SESE | | [K924347](https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/KIE/K924347.md) | WATERS(TM) 996 PDA | Millipore Corp. | Dec 11, 1992 | SESE | | [K914841](https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/KIE/K914841.md) | CHROMATOGRAPHY CLINICAL USE 75JQR | Millipore Corp. | Dec 10, 1991 | SESE | | [K911299](https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/KIE/K911299.md) | EQUIPMENT/MATERIAL DECONTAMINATING KIT | Rohm and Haas Co. | Apr 8, 1991 | SESE | | [K862506](https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/KIE/K862506.md) | THE WATERS MODEL 990 PHOTODIODE ARRAY DETECTOR | Millipore Corp. | Jul 29, 1986 | SESE | | [K844947](https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/KIE/K844947.md) | EMIT ANCILLARY REAGENTS | Syva Co. | Jun 28, 1985 | SESE | | [K844949](https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/KIE/K844949.md) | SYVA SAMPLE SEAL | Syva Co. | Feb 15, 1985 | SESE | | [K800556](https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/KIE/K800556.md) | DIFFERENTIAL REFRACTIVE INDEX DETECTOR | Hewlett-Packard Co. | Mar 25, 1980 | SESE | | [K800516](https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/KIE/K800516.md) | DUPONT INSTRUMENTS MODEL 870 LIQ. CHROM. | E.I. Dupont DE Nemours & Co., Inc. | Mar 19, 1980 | SESE | | [K800289](https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/KIE/K800289.md) | LDC SPECTROMONITOR III | Laboratory Data Control | Feb 26, 1980 | SESE | | [K800046](https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/KIE/K800046.md) | LDC CHROMATOGRAPHY ACCESSORY MODULE B | Laboratory Data Control | Feb 25, 1980 | SESE | | [K800048](https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/KIE/K800048.md) | LDC CONSTAMETRIC III HIGHT PRESS. SOL. | Laboratory Data Control | Jan 29, 1980 | SESE | | [K800047](https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/KIE/K800047.md) | LDC UVIII FIXED WAVELENGTH ULTRAVIOLET | Laboratory Data Control | Jan 21, 1980 | SESE | | [K791661](https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/KIE/K791661.md) | SYSTEM CONTROLLER 720 SERIES | Waters Assoc., Inc. | Sep 24, 1979 | SESE | | [K790145](https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/KIE/K790145.md) | SOLVENT DELIVERY SYSTEM | Waters Assoc., Inc. | Feb 15, 1979 | SESE | | [K782175](https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/KIE/K782175.md) | CARTRIDGE HOLDER, RCM 100 | Waters Assoc., Inc. | Feb 15, 1979 | SESE | | [K781915](https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/KIE/K781915.md) | DATA MODULE | Waters Assoc., Inc. | Jan 10, 1979 | SESE | | [K781771](https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/KIE/K781771.md) | DETECTOR, MODEL 79875A, VARIABLE | Hewlett-Packard Co. | Dec 20, 1978 | SESE | | [K781379](https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/KIE/K781379.md) | 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 --- **Source:** [https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/KIE](https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/KIE) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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