← Product Code [DOP](/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/DOP) · K854076

# MGA 2000 GAS ANALYSER (K854076)

_Airspec , Ltd. · DOP · Dec 11, 1985 · Clinical Chemistry · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/TX/subpart-c%E2%80%94clinical-laboratory-instruments/DOP/K854076

## Device Facts

- **Applicant:** Airspec , Ltd.
- **Product Code:** [DOP](/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/DOP.md)
- **Decision Date:** Dec 11, 1985
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 862.2860
- **Device Class:** Class 1
- **Review Panel:** Clinical Chemistry

## Regulatory Identification

A mass spectrometer for clinical use is a device intended to identify inorganic or organic compounds (e.g., lead, mercury, and drugs) in human specimens by ionizing the compound under investigation and separating the resulting ions by means of an electrical and magnetic field according to their mass.

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**Source:** [https://fda.innolitics.com/submissions/TX/subpart-c%E2%80%94clinical-laboratory-instruments/DOP/K854076](https://fda.innolitics.com/submissions/TX/subpart-c%E2%80%94clinical-laboratory-instruments/DOP/K854076)

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