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Data / Medical devices / Electrode, Ion Specific, Calcium

Electrode, Ion Specific, Calcium (JFP): 29 FDA-registered makers in 10 countries

29 establishments in 10 countries are registered with the FDA to make Electrode, Ion Specific, Calcium (product code JFP, Class 2, 21 CFR 862.1145). 8 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 29 510(k) clearances under this code, the latest on October 27, 2023, and lists 4 recall events (0 Class I). FDA data exported November 2, 2026.

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Product code
JFP
Device class
2
Regulation
862.1145
Medical specialty
Clinical Chemistry

Makers by country

CountryMakers
United States17
Canada3
Poland2
Hungary1
Switzerland1
Ireland1
China1
Germany1
Denmark1
United Kingdom1

Makers of Electrode, Ion Specific, Calcium

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
Medica Corp.Bedford, MA, United StatesManufacturer3December 1, 2016000api.fda.gov
Abbott Point Of Care Canada LimitedOttawa Ontario, CanadaManufacturer2October 27, 2023000api.fda.gov
Abbott Point Of Care Inc.Princeton, NJ, United StatesComplaint file establishment, Manufacturer, Specification developer2October 27, 2023000api.fda.gov
Diamond Diagnostics Inc.Budapest, HungaryContract manufacturer, Exporter to the US1June 12, 1996000api.fda.gov
Nova Biomedical CorporationWaltham, MA, United StatesComplaint file establishment, Manufacturer, Manufacturer for export, Remanufacturer1August 16, 2019000api.fda.gov
Nova Biomedical CorporationBillerica, MA, United StatesManufacturer, Manufacturer for export, Remanufacturer1August 16, 2019000api.fda.gov
Opti Medical Systems Inc.Roswell, GA, United StatesManufacturer1December 11, 1998000api.fda.gov
Roche Diagnostics International Ltd.ROTKREUZ Zug, SwitzerlandManufacturer1June 12, 1996000api.fda.gov
Beckman Coulter, Inc.Brea, CA, United StatesManufacturer, Specification developer0000api.fda.gov
Beckman Coulter, Inc.Carlsbad, CA, United StatesContract manufacturer0000api.fda.gov
Bionostics, Inc.Devens, MA, United StatesContract manufacturer0000api.fda.gov
Beckman Coulter Ireland IncO CALLAGHANS MILLS Clare, IrelandContract manufacturer0000api.fda.gov
Carolina Liquid ChemistriesBrea, CA, United StatesManufacturer0000api.fda.gov
DIAMOND DIAGNOSTICS IncHolliston, MA, United StatesManufacturer0000api.fda.gov
Edan Instruments, Inc.Shenzhen Guangdong, ChinaManufacturer0000api.fda.gov
Epocal, Inc.Ottawa Ontario, CanadaManufacturer, Specification developer0000api.fda.gov
Epocal IncOttawa Ontario, CanadaManufacturer, Specification developer0000api.fda.gov
Fisher DiagnosticsMiddletown, VA, United StatesContract manufacturer0000api.fda.gov
Instrumentation Laboratory Co.Bedford, MA, United StatesManufacturer0000api.fda.gov
Instrumentation Laboratory Co.Orangeburg, NY, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
Philips Medizin Systeme Boeblingen GmbHBOEBLINGEN Baden-Wurttemberg, GermanyComplaint file establishment, Specification developer0000api.fda.gov
Radiometer Medical ApsBROENSHOEJ Hovedstaden, DenmarkComplaint file establishment, Manufacturer0000api.fda.gov
Radiometer MinneapolisNew Brighton, MN, United StatesManufacturer0000api.fda.gov
Radiometer Solutions Sp. z o.o.Stargard Zachodniopomorskie, PolandContract manufacturer0000api.fda.gov
Radiometer Sp. z o.oStargard Zachodniopomorskie, PolandContract manufacturer0000api.fda.gov
Siemens Healthcare Diagnostics Manufacturing LtdSUDBURY Suffolk, United KingdomManufacturer, Specification developer0000api.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

Updated October 27, 2023. 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.