← Product Code [JJG](/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/JJG) · K934592

# EPOC 2000 POINT-OF-CARE ANALYZER AND EPOC 5-CHEMISTRY REAGENT ROTOR (K934592)

_Abaxis, Inc. · JJG · Apr 6, 1994 · Clinical Chemistry · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/JJG/K934592

## Device Facts

- **Applicant:** Abaxis, Inc.
- **Product Code:** [JJG](/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/JJG.md)
- **Decision Date:** Apr 6, 1994
- **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/K934592](https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/JJG/K934592)

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