Incos 50 Mass Spectrometer

FDA 510(k) K880418 · Finnigan Corp.

Substantially Equivalent

510(k) numberK880418

Submission

Device name
Incos 50 Mass Spectrometer
Applicant
Finnigan Corp.
Livingston, NJ, US
Received
February 1, 1988
Decision date
May 31, 1988
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
DOP – Mass Spectrometer, Clinical Use
Device class
Class I (low risk)
Regulation
21 CFR 862.2860
Specialty
Clinical Chemistry

Other 510(k)s with product code DOP

510(k)DeviceApplicantDecision
K992163Abca Gas Isotope Ratio Mass Spectrometer SystemsDOP · Special Pdz-Europa , Ltd.07/13/1999SE
K974322Abca-Nt Gas Isotope Ratio Mass Spectrometer SystemDOP · Traditional Europa Scientific, Ltd.12/16/1997SE
K880090Ion Trap DetectorDOP · Traditional Finnigan Corp.03/15/1988SE
K880089Finnigan Mat TSQ-70DOP · Traditional Finnigan Corp.02/11/1988SE
K872464Ion Trap Detector (Itd)DOP · Traditional The Perkin-Elmer Corp.08/11/1987SE
K854076Mga 2000 Gas AnalyserDOP · Traditional Airspec , Ltd.12/11/1985SE
K810938Mass Spectrometer-Medspect IIDOP · Traditional Allied Healthcare Products, Inc.04/23/1981SE
K770994Furnace Autosampler, Model 155DOP · Traditional Instrumentation Laboratory CO08/22/1977SE
K770637Mercury/Hydride System MHS-1DOP · Traditional The Perkin-Elmer Corp.06/23/1977SE

More from The Perkin-Elmer Corp.

510(k)DeviceDecision
K880090Ion Trap DetectorDOP · Traditional 03/15/1988SE
K880089Finnigan Mat TSQ-70DOP · Traditional 02/11/1988SE
K873603Finnigan Mat Incos 50JJO · Traditional 09/22/1987SE

Questions and answers

When was Incos 50 Mass Spectrometer cleared by the FDA?

Incos 50 Mass Spectrometer (K880418) received a 510(k) decision of Substantially Equivalent on May 31, 1988, 120 days after the submission was received.

What is the product code of K880418?

The FDA product code is DOP – Mass Spectrometer, Clinical Use, a Class I (low risk) device regulated under 21 CFR 862.2860.