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) → LDM — Instrumentation, High Pressure Liquid Chromatography # LDM · Instrumentation, 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/LDM ## Overview - **Product Code:** LDM - **Device Name:** Instrumentation, 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 (19 of 19) | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K960392](https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/LDM/K960392.md) | CDM | Bio-Rad | Jul 8, 1996 | SESE | | [K961557](https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/LDM/K961557.md) | ALLIANCE 2690 SEPARATIONS MODULE | Waters Corporation | Jul 5, 1996 | SESE | | [K942451](https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/LDM/K942451.md) | BIO-RAD CLINICAL DATA MANAGEMENT SYSTEM | Bio-Rad | Nov 10, 1994 | SESE | | [K922388](https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/LDM/K922388.md) | WATERS(TM) LC MODULE I FOR CLINICAL USE | Millipore Corp. | Sep 11, 1992 | SESE | | [K920136](https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/LDM/K920136.md) | WATERS 717 AUTOSAMPLER | Millipore Corp. | Feb 19, 1992 | SESE | | [K903647](https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/LDM/K903647.md) | MODULE 486 VARIABLE WAVELENGTH TUNABLE UV/VIS DETE | Millipore Corp. | Sep 11, 1990 | SESE | | [K884886](https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/LDM/K884886.md) | MODEL 250 LIQUID CHROMOTAGRAPHY PUMP | The Perkin-Elmer Corp. | Feb 2, 1989 | SESE | | [K872582](https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/LDM/K872582.md) | HIGH PRESSURE LIQUID CHROMATOGRAPHY SYSTEM | Millipore Corp. | Jul 16, 1987 | SESE | | [K870949](https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/LDM/K870949.md) | WATERS 650 ADVANCED PROTEIN PURIFICATION SYSTEM | Millipore Corp. | Apr 22, 1987 | SESE | | [K862178](https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/LDM/K862178.md) | ISOPURE LC SYSTEM | The Perkin-Elmer Corp. | Jul 14, 1986 | SESE | | [K850272](https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/LDM/K850272.md) | WATERS 740 DATA MODULE-PLOTTER INTEGRATOR | Millipore Corp. | Mar 6, 1985 | SESE | | [K850359](https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/LDM/K850359.md) | WATERS 460 LIQUID CHROMATOGRAPHY ELECTROCHEMICAL D | Millipore Corp. | Mar 5, 1985 | SESE | | [K833113](https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/LDM/K833113.md) | REPORTING INTEGRATOR 3392A | Hewlett-Packard Co. | Nov 21, 1983 | SESE | | [K832375](https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/LDM/K832375.md) | LIQUID CHROMATOGRAPH 1090 SERIES | Hewlett-Packard Co. | Oct 14, 1983 | SESE | | [K821727](https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/LDM/K821727.md) | SERIES 10 LIQUID CHROMOTOGRAPH | The Perkin-Elmer Corp. | Jun 22, 1982 | SESE | | [K821219](https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/LDM/K821219.md) | SERIES 4 LIQUID CHROMATOGRAPH | The Perkin-Elmer Corp. | May 28, 1982 | SESE | | [K810304](https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/LDM/K810304.md) | MODEL LC-85 UV DETECTOR | The Perkin-Elmer Corp. | Feb 25, 1981 | SESE | | [K802031](https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/LDM/K802031.md) | 3390A REPORTING INTEGRATOR | Hewlett-Packard Co. | Sep 16, 1980 | SESE | | [K780933](https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/LDM/K780933.md) | 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 - E.I. Dupont DE Nemours & Co., Inc. — 1 clearance --- **Source:** [https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/LDM](https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/LDM) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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