MASS SPECTROMETER-MEDSPECT II
Device Facts
| Record ID | K810938 |
|---|---|
| Device Name | MASS SPECTROMETER-MEDSPECT II |
| Applicant | Allied Healthcare Products, Inc. |
| Product Code | DOP · Clinical Chemistry |
| Decision Date | Apr 23, 1981 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.2860 |
| Device Class | Class 1 |
Regulatory Classification
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.
