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) → DPM — Columns, Liquid Chromatography

# DPM · Columns, 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/DPM

## Overview

- **Product Code:** DPM
- **Device Name:** Columns, 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 (16 of 16)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K952501](https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/DPM/K952501.md) | TOX PERFECT B TUBES AND REAGENTS | Chimera Research & Chemical, Inc. | Aug 24, 1995 | SESE |
| [K895105](https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/DPM/K895105.md) | HIGH PRESSURE INERT PLASTIC COLUMNS FOR CLIN. USE | Waters Chemical Products | Oct 6, 1989 | SESE |
| [K894141](https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/DPM/K894141.md) | LIQUID CHROMATOGRAPHY COLUMNS | Supelco, Inc. | Aug 21, 1989 | SESE |
| [K891673](https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/DPM/K891673.md) | ADVANCED PURIFICATION GLASS COLUMN | Waters Chemical Products | Apr 26, 1989 | SESE |
| [K884403](https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/DPM/K884403.md) | LIQUID CHROMATOGRAPHY COLUMNS SOLID PHASE EX. TUBE | Supelco, Inc. | Dec 22, 1988 | SESE |
| [K881868](https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/DPM/K881868.md) | LIQUID CHROMATOGRAPHY COLUMNS HISEP COLUMN & GUARD | Supelco, Inc. | Aug 29, 1988 | SESE |
| [K880724](https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/DPM/K880724.md) | LIQUID CHROMATO. COLUMNS | Supelco, Inc. | May 27, 1988 | SESE |
| [K864267](https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/DPM/K864267.md) | SEP-PAK CARTRIDGES (LIQUID CHROMATOGRAPHY) | Millipore Corp. | Jan 9, 1987 | SESE |
| [K862541](https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/DPM/K862541.md) | LIQUID CHROMATOGRAPHY COLUMNS | Supelco, Inc. | Jul 29, 1986 | SESE |
| [K861633](https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/DPM/K861633.md) | LIQUID CHROMATOGRAPHY COLUMNS | Supelco, Inc. | May 23, 1986 | SESE |
| [K842909](https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/DPM/K842909.md) | LIQUID CHROMATOGRAPHY COLUMNS;ION EXCH | Supelco, Inc. | Oct 5, 1984 | SESE |
| [K832200](https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/DPM/K832200.md) | PRP-1 REVERSED PHASE COLUMNS FOR HPLC | Hamilton Co. | Aug 16, 1983 | SESE |
| [K813575](https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/DPM/K813575.md) | LIQUID CHROMATOGRAPHY (HPLC) COLUMNS | Supelco, Inc. | Jan 18, 1982 | SESE |
| [K811304](https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/DPM/K811304.md) | LIQUID CHROMATOGRAPHY COLUMNS | Supelco, Inc. | May 27, 1981 | SESE |
| [K802703](https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/DPM/K802703.md) | LIQUID CHROMATOGRAPHY COLUMNS | Supelco, Inc. | Nov 12, 1980 | SESE |
| [K761168](https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/DPM/K761168.md) | MAX L SYSTEM | Brinkman Instruments, Inc. | Dec 10, 1976 | SESE |

## Top Applicants

- Supelco, Inc. — 10 clearances
- Waters Chemical Products — 2 clearances
- Brinkman Instruments, Inc. — 1 clearance
- Chimera Research & Chemical, Inc. — 1 clearance
- Hamilton Co. — 1 clearance

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**Source:** [https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/DPM](https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/DPM)

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