DOP · Mass Spectrometer, Clinical Use
Clinical Chemistry · 21 CFR 862.2860 · Class 1
Overview
| Product Code | DOP |
|---|---|
| Device Name | Mass Spectrometer, Clinical Use |
| Regulation | 21 CFR 862.2860 |
| Device Class | Class 1 |
| Review Panel | Clinical Chemistry |
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.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.
Recent Cleared Devices (10 of 10)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K992163 | ABCA GAS ISOTOPE RATIO MASS SPECTROMETER SYSTEMS | Pdz-Europa , Ltd. | Jul 13, 1999 | SESE |
| K974322 | ABCA-NT GAS ISOTOPE RATIO MASS SPECTROMETER SYSTEM | Europa Scientific, Ltd. | Dec 16, 1997 | SESE |
| K880418 | INCOS 50 MASS SPECTROMETER | Finnigan Corp. | May 31, 1988 | SESE |
| K880090 | ION TRAP DETECTOR | Finnigan Corp. | Mar 15, 1988 | SESE |
| K880089 | FINNIGAN MAT TSQ-70 | Finnigan Corp. | Feb 11, 1988 | SESE |
| K872464 | ION TRAP DETECTOR (ITD) | The Perkin-Elmer Corp. | Aug 11, 1987 | SESE |
| K854076 | MGA 2000 GAS ANALYSER | Airspec , Ltd. | Dec 11, 1985 | SESE |
| K810938 | MASS SPECTROMETER-MEDSPECT II | Allied Healthcare Products, Inc. | Apr 23, 1981 | SESE |
| K770994 | FURNACE AUTOSAMPLER, MODEL 155 | Instrumentation Laboratory CO | Aug 22, 1977 | SESE |
| K770637 | MERCURY/HYDRIDE SYSTEM MHS-1 | The Perkin-Elmer Corp. | Jun 23, 1977 | SESE |
Top Applicants
- Finnigan Corp. — 3 clearances
- The Perkin-Elmer Corp. — 2 clearances
- Pdz-Europa , Ltd. — 1 clearance
- Instrumentation Laboratory CO — 1 clearance
- Europa Scientific, Ltd. — 1 clearance
