Modular Mass Spectrometer (M.S.)
by The Perkin-Elmer Corp. 510(k)
Active
510(k) K862605
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK862605 | Date13 Aug 1986 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- CCK
- Device Class
- Class II
- Regulation
- 21 CFR Part 868.1400
- Advisory Committee
- Anesthesiology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 27 Sep 2026
The device is a modular mass spectrometer (M.S.), which is a type of analytical instrument used to identify and quantify chemical substances by measuring the mass-to-charge ratio of ions. It is designed to be interfaced with a gas chromatograph (GC) for combined GC/MS analysis, enabling the separation and detection of volatile and semi-volatile compounds in complex mixtures.
The device is supplied as a detector component intended for use with the Clarus 600 Gas Chromatograph system and is controlled via PerkinElmer TurboMass™ GC/MS software. It is a reusable instrument requiring appropriate calibration and maintenance, and its use is restricted to laboratory settings. The device received FDA 510(k) clearance (K862605) on August 13, 1986, and is classified under product code CCK with review by the Anesthesiology advisory committee.
Other devices from The Perkin-Elmer Corp.
Questions
AI-generated answers, 27 Sep 2026
What is the Modular Mass Spectrometer (M.S.) used for?
The Modular Mass Spectrometer (M.S.) is an analytical instrument used to identify and quantify chemical substances by measuring the mass-to-charge ratio of ions. It is designed to be interfaced with a gas chromatograph (GC) for combined GC/MS analysis, enabling the separation and detection of volatile and semi-volatile compounds in complex mixtures.
How is the Modular Mass Spectrometer (M.S.) supplied and what system is it compatible with?
The device is supplied as a detector component intended for use with the Clarus 600 Gas Chromatograph system and is controlled via PerkinElmer TurboMass™ GC/MS software. It is not a standalone unit but functions as part of an integrated GC/MS setup.
Is the Modular Mass Spectrometer (M.S.) reusable or single-use, and where is it intended for use?
The Modular Mass Spectrometer (M.S.) is a reusable instrument that requires appropriate calibration and maintenance. Its use is restricted to laboratory settings, as it is not designed for point-of-care or clinical bedside applications.