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Data / Medical devices / Mass Spectrometer, Clinical Use

Mass Spectrometer, Clinical Use (DOP): 16 FDA-registered makers in 9 countries

16 establishments in 9 countries are registered with the FDA to make Mass Spectrometer, Clinical Use (product code DOP, Class 1, 21 CFR 862.2860). 1 of them has a 510(k) clearance or PMA approval on file and 3 have a recall event. The FDA has issued 10 510(k) clearances under this code, the latest on July 13, 1999, and lists 10 recall events (0 Class I). FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Get every maker of this deviceMakers in the United StatesWatch this device
Product code
DOP
Device class
1
Regulation
862.2860
Medical specialty
Clinical Chemistry

Makers by country

CountryMakers
United States4
United Kingdom2
Singapore2
Japan2
China2
Canada1
Germany1
Finland1
Ireland1

Makers of Mass Spectrometer, Clinical Use

Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Sercon Limitedcrewe Cheshire East, United KingdomComplaint file establishment, Manufacturer1July 13, 1999000api.fda.gov
AB Sciex LPConcord Ontario, CanadaComplaint file establishment, Specification developer0010api.fda.gov
AB SCIEX Pte. Ltd.Woodlands Central Industrial Estate Central Singapore, SingaporeManufacturer0000api.fda.gov
Agena Bioscience IncorporatedSan Diego, CA, United StatesManufacturer0000api.fda.gov
Agilent Technologies Singapore (International) Pte Ltd.Singapore North East, SingaporeManufacturer0000api.fda.gov
Agilent Technologies, IncSanta Clara, CA, United StatesSpecification developer0010api.fda.gov
Hitachi High-Tech Corp., Naka DivisionHitachinaka-shi Ibaraki, JapanContract manufacturer0000api.fda.gov
Labpeak Co.,ltdJinan Shandong, ChinaExporter to the US, Manufacturer0000api.fda.gov
Roche Diagnostics GMBHMANNHEIM Baden-Wurttemberg, GermanySpecification developer0000api.fda.gov
Scitek Global Co.,ltdJinan Shandong, ChinaExporter to the US, Manufacturer0000api.fda.gov
Shimadzu Corporation Analytical&measuring Instruments Div.Kyoto, JapanComplaint file establishment, Specification developer0000api.fda.gov
Shimadzu U.S.A. Manufacturing, Inc.Canby, OR, United StatesContract manufacturer0000api.fda.gov
Thermo Finnigan LLCSan Jose, CA, United StatesManufacturer0010api.fda.gov
Wallac OYTURKU Varsinais-Suomi, FinlandExporter to the US, Manufacturer0000api.fda.gov
Waters Technologies CorporationWILMSLOW Manchester, United KingdomManufacturer, Specification developer0000api.fda.gov
Waters Technologies Ireland, Ltd.DRINAGH Wexford, IrelandManufacturer0000api.fda.gov

Updated July 13, 1999. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.