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) → DMZ — Liquid Chromatography, Adsorbent

# DMZ · Liquid Chromatography, Adsorbent

_Clinical Chemistry · 21 CFR 862.2260 · Class 1_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/DMZ

## Overview

- **Product Code:** DMZ
- **Device Name:** Liquid Chromatography, Adsorbent
- **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 (1 of 1)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K832197](https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/DMZ/K832197.md) | PRP-1 REVERSED PHASE RESIN | Hamilton Co. | Aug 12, 1983 | SESE |

## Top Applicants

- Hamilton Co. — 1 clearance

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

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