← Product Code [JJG](/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/JJG) · K854055

# I.C.L.S. COMPULYZER (K854055)

_Integrated Computerized Laboratory Systems, Inc. · JJG · Nov 19, 1985 · Clinical Chemistry · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/JJG/K854055

## Device Facts

- **Applicant:** Integrated Computerized Laboratory Systems, Inc.
- **Product Code:** [JJG](/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/JJG.md)
- **Decision Date:** Nov 19, 1985
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 862.2140
- **Device Class:** Class 1
- **Review Panel:** Clinical Chemistry

## Regulatory Identification

A centrifugal chemistry analyzer for clinical use is an automatic device intended to centrifugally mix a sample and a reagent and spectrophotometrically measure concentrations of the sample constituents. This device is intended for use in conjunction with certain materials to measure a variety of analytes.

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**Source:** [https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/JJG/K854055](https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/JJG/K854055)

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