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Modular Mass Spectrometer (M.S.)

by The Perkin-Elmer Corp. 510(k)

Active United States

510(k) K862605

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK862605 Date13 Aug 1986ClearedStatusActive

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

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

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

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.

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Questions

AI-generated answers, 27 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • 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.