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) → KZR — Chromatography (Liquid, Gel), Clinical Use

# KZR · Chromatography (Liquid, Gel), Clinical Use

_Clinical Chemistry · 21 CFR 862.2260 · Class 1_

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

## Overview

- **Product Code:** KZR
- **Device Name:** Chromatography (Liquid, Gel), Clinical Use
- **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 (15 of 15)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K973074](https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/KZR/K973074.md) | 2487 DUAL WAVELENGTH ABSORBANCE DETECTOR | Waters Corporation | Oct 6, 1997 | SESE |
| [K931227](https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/KZR/K931227.md) | USDT FLOW IMMUNOASSAY SYSTEM, MODEL 9000 | U.S. Drug Testing, Inc. | May 6, 1993 | SESE |
| [K905538](https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/KZR/K905538.md) | COLUMNS LIQUID CHROMATOGRAPHY DPM | Millpore Corp. | Jan 25, 1991 | SESE |
| [K861392](https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/KZR/K861392.md) | SYVA SOLID PHASE COLUMNS SYSTEM II | Syva Co. | Jun 13, 1986 | SESE |
| [K860197](https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/KZR/K860197.md) | SERIES 410 LC PUMP | The Perkin-Elmer Corp. | Mar 17, 1986 | SESE |
| [K851945](https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/KZR/K851945.md) | VARIAN AASP AUTOMATED SAMPLE PREP. SYSTEM | Varian Assoc., Inc. | May 24, 1985 | SESE |
| [K843568](https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/KZR/K843568.md) | LIQUID CHROMATOGRAPH 400 | The Perkin-Elmer Corp. | Nov 20, 1984 | SESE |
| [K841890](https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/KZR/K841890.md) | VARIAN 2000 LIQUID CHROMATOGRAPHY ANALY | Varian Assoc., Inc. | Jun 14, 1984 | SESE |
| [K840977](https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/KZR/K840977.md) | LIQUID CHROMATOGRAPHIC DETECTOR LC-95 | The Perkin-Elmer Corp. | Apr 19, 1984 | SESE |
| [K832201](https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/KZR/K832201.md) | CHROM-PREP | Hamilton Co. | Aug 16, 1983 | SESE |
| [K802725](https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/KZR/K802725.md) | VISTA 54 LIQUID CHROMATOGRAPHY ANAL. SYS | Varian Assoc., Inc. | Dec 11, 1980 | SESE |
| [K780945](https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/KZR/K780945.md) | LIQUID CHROMATOGRAPH MODEL 860 | E.I. Dupont DE Nemours & Co., Inc. | Jul 27, 1978 | SESE |
| [K780944](https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/KZR/K780944.md) | LIQUID CHROMATOGRAPH MODEL 850 | E.I. Dupont DE Nemours & Co., Inc. | Jul 27, 1978 | SESE |
| [K770255](https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/KZR/K770255.md) | LC-65T DETECTOR AND OVEN | The Perkin-Elmer Corp. | Feb 25, 1977 | SESE |
| [K770254](https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/KZR/K770254.md) | CHROMATOGRAPH, SERIES 3, LIQUID | The Perkin-Elmer Corp. | Feb 24, 1977 | SESE |

## Top Applicants

- The Perkin-Elmer Corp. — 5 clearances
- Varian Assoc., Inc. — 3 clearances
- E.I. Dupont DE Nemours & Co., Inc. — 2 clearances
- Hamilton Co. — 1 clearance
- Millpore Corp. — 1 clearance

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

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