← Product Code [JJF](/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/JJF) · K790197

# REAGENT KIT, LANCER GLUCOSE (K790197)

_Sherwood Medical Industries · JJF · Mar 12, 1979 · Clinical Chemistry · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/JJF/K790197

## Device Facts

- **Applicant:** Sherwood Medical Industries
- **Product Code:** [JJF](/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/JJF.md)
- **Decision Date:** Mar 12, 1979
- **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/K790197](https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/JJF/K790197)

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