← Product Code [DOP](/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/DOP) · K810938

# MASS SPECTROMETER-MEDSPECT II (K810938)

_Allied Healthcare Products, Inc. · DOP · Apr 23, 1981 · Clinical Chemistry · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/TX/subpart-c%E2%80%94clinical-laboratory-instruments/DOP/K810938

## Device Facts

- **Applicant:** Allied Healthcare Products, Inc.
- **Product Code:** [DOP](/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/DOP.md)
- **Decision Date:** Apr 23, 1981
- **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/K810938](https://fda.innolitics.com/submissions/TX/subpart-c%E2%80%94clinical-laboratory-instruments/DOP/K810938)

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