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Data / Medical devices / Electrode, Ion Specific, Potassium / United States

FDA-registered makers of Electrode, Ion Specific, Potassium in the United States: 33 establishments

33 establishments in the United States are registered with the FDA to make Electrode, Ion Specific, Potassium (product code CEM). 10 have a 510(k) clearance or PMA approval on file and 7 have a recall event. FDA data exported November 3, 2026.

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Device
Electrode, Ion Specific, Potassium
Product code
CEM
Country
United States

Makers of Electrode, Ion Specific, Potassium in the United States

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
DIAMOND DIAGNOSTICS IncHolliston, MA, United StatesManufacturer2October 1, 2020000api.fda.gov
Nova Biomedical CorporationWaltham, MA, United StatesComplaint file establishment, Contract manufacturer, Manufacturer, Manufacturer for export, Remanufacturer2January 27, 1992000api.fda.gov
Opti Medical Systems Inc.Roswell, GA, United StatesManufacturer2August 4, 2006000api.fda.gov
Abbott LaboratoriesIrving, TX, United StatesManufacturer, Specification developer1February 19, 2010010api.fda.gov
Beckman Coulter, Inc.Brea, CA, United StatesManufacturer, Specification developer1November 12, 2004050api.fda.gov
Instrumentation Laboratory Co.Bedford, MA, United StatesManufacturer1May 3, 2012010api.fda.gov
Instrumentation Laboratory Co.Orangeburg, NY, United StatesManufacturer, Repackager or relabeler1May 3, 2012000api.fda.gov
Ortho-Clinical Diagnostics, Inc.Rochester, NY, United StatesComplaint file establishment, Specification developer1December 7, 2007010api.fda.gov
Ortho-Clinical Diagnostics, Inc.Rochester, NY, United StatesManufacturer1December 7, 2007010api.fda.gov
Siemens Healthcare Diagnostics Inc.Newark, DE, United StatesManufacturer, Specification developer1April 14, 1997020api.fda.gov
Abaxis, Inc.Union City, CA, United StatesManufacturer0000api.fda.gov
Abbott Point Of Care Inc.Princeton, NJ, United StatesComplaint file establishment, Manufacturer, Specification developer0000api.fda.gov
Alfa WassermannWest Caldwell, NJ, United StatesComplaint file establishment, Manufacturer, Repackager or relabeler, Specification developer0000api.fda.gov
Awareness Technology, Inc.Palm City, FL, United StatesManufacturer0000api.fda.gov
Beckman Coulter, Inc.Carlsbad, CA, United StatesContract manufacturer0000api.fda.gov
Bionostics, Inc.Devens, MA, United StatesContract manufacturer0000api.fda.gov
Cliniqa CorporationSan Marcos, CA, United StatesContract manufacturer0000api.fda.gov
Currier PlasticsAuburn, NY, United StatesContract manufacturer0000api.fda.gov
Carolina Liquid ChemistriesBrea, CA, United StatesComplaint file establishment, Manufacturer, Specification developer0000api.fda.gov
ELITechGroup IncLogan, UT, United StatesContract manufacturer0000api.fda.gov
Fisher DiagnosticsMiddletown, VA, United StatesContract manufacturer0000api.fda.gov
Infrared Laboratory Systems dba SYNERMEDWestfield, IN, United StatesManufacturer0000api.fda.gov
Medica Corp.Bedford, MA, United StatesManufacturer0010api.fda.gov
Nova Biomedical CorporationBillerica, MA, United StatesManufacturer, Manufacturer for export, Remanufacturer0000api.fda.gov
Nypro Inc. (Chicago)Gurnee, IL, United StatesContract manufacturer0000api.fda.gov
Phoenix Diagnostics, Inc.Natick, MA, United StatesManufacturer0000api.fda.gov
Radiometer MinneapolisNew Brighton, MN, United StatesManufacturer0000api.fda.gov
Sanzay Corporation -Miami Gardens, FL, United StatesRemanufacturer0000api.fda.gov
Scientific Supplies & Technology, Inc.Doral, FL, United StatesRemanufacturer, Repackager or relabeler0000api.fda.gov
Siemens Healthcare Diagnostics IncEast Walpole, MA, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Siemens Healthcare Diagnostics Inc.Tarrytown, NY, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Siemens Healthcare Diagnostics Inc.E Walpole, MA, United StatesManufacturer0000api.fda.gov
Tessy Plastics Corp.Elbridge, NY, United StatesContract manufacturer0000api.fda.gov

Updated November 3, 2026. 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.