← Product Code [LDM](/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/LDM) · K862178

# ISOPURE LC SYSTEM (K862178)

_The Perkin-Elmer Corp. · LDM · Jul 14, 1986 · Clinical Chemistry · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/LDM/K862178

## Device Facts

- **Applicant:** The Perkin-Elmer Corp.
- **Product Code:** [LDM](/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/LDM.md)
- **Decision Date:** Jul 14, 1986
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 862.2260
- **Device Class:** Class 1
- **Review Panel:** Clinical Chemistry

## Regulatory 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.

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**Source:** [https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/LDM/K862178](https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/LDM/K862178)

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