← Product Code [JJF](/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/JJF) · K802392

# ASTRA PRINTER PAPER #88112-CHLORIDE SILV (K802392)

_Hi Chem, Inc. · JJF · Oct 23, 1980 · Clinical Chemistry · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/JJF/K802392

## Device Facts

- **Applicant:** Hi Chem, Inc.
- **Product Code:** [JJF](/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/JJF.md)
- **Decision Date:** Oct 23, 1980
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 862.2170
- **Device Class:** Class 1
- **Review Panel:** Clinical Chemistry

## Regulatory Identification

A micro chemistry analyzer for clinical use is a device intended to duplicate manual analytical procedures by performing automatically various steps such as pipetting, preparing filtrates, heating, and measuring color intensity. The distinguishing characteristic of the device is that it requires only micro volume samples obtainable from pediatric patients. 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/JJF/K802392](https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/JJF/K802392)

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