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Data / Medical devices / Electrode, Ion-Specific, Chloride

Electrode, Ion-Specific, Chloride (CGZ): 69 FDA-registered makers in 15 countries

69 establishments in 15 countries are registered with the FDA to make Electrode, Ion-Specific, Chloride (product code CGZ, Class 2, 21 CFR 862.1170). 10 of them have a 510(k) clearance or PMA approval on file and 3 have a recall event. The FDA has issued 38 510(k) clearances under this code, the latest on October 30, 2018, and lists 10 recall events (0 Class I). FDA data exported November 2, 2026.

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Product code
CGZ
Device class
2
Regulation
862.1170
Medical specialty
Clinical Chemistry

Makers by country

CountryMakers
United States32
Japan8
Germany6
Canada4
China3
United Kingdom3
Italy2
France2
Switzerland2
Poland2
Mexico1
Hungary1
Denmark1
Ireland1
Netherlands1

Makers of Electrode, Ion-Specific, Chloride

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
Abbott LaboratoriesIrving, TX, United StatesManufacturer, Specification developer2October 24, 2017000api.fda.gov
Medica Corp.Bedford, MA, United StatesManufacturer2May 15, 2000000api.fda.gov
Nova Biomedical CorporationWaltham, MA, United StatesComplaint file establishment, Contract manufacturer, Manufacturer, Manufacturer for export, Remanufacturer2November 6, 1992000api.fda.gov
Phoenix Diagnostics, Inc.Natick, MA, United StatesManufacturer2February 4, 2002000api.fda.gov
ELITechGroup IncLogan, UT, United StatesContract manufacturer, Manufacturer1May 24, 1988000api.fda.gov
Infrared Laboratory Systems dba SYNERMEDWestfield, IN, United StatesManufacturer1March 3, 1997000api.fda.gov
Opti Medical Systems Inc.Roswell, GA, United StatesManufacturer1September 29, 2005020api.fda.gov
Ortho-Clinical Diagnostics, Inc.Rochester, NY, United StatesComplaint file establishment, Specification developer1October 30, 2018020api.fda.gov
Ortho-Clinical Diagnostics, Inc.Rochester, NY, United StatesManufacturer1October 30, 2018010api.fda.gov
Siemens Healthcare Diagnostics Inc.Tarrytown, NY, United StatesComplaint file establishment, Specification developer1May 15, 2000000api.fda.gov
Abbott Point Of Care Canada LimitedOttawa Ontario, CanadaManufacturer0000api.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
Abbott Automation Solutions GmbHHamburg, GermanyManufacturer0000api.fda.gov
Abbott Laboratories de MexicoCuautitlan Izcalli Mexico, MexicoContract manufacturer0000api.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
BIOTECNICA INSTRUMENTS, SrlROME Roma, ItalyManufacturer0000api.fda.gov
Beckman Coulter K. K.Sunto-Gun Shizuoka, JapanSpecification developer0000api.fda.gov
Beckman Coulter Mishima K.K.SUNTO-GUN Shizuoka, JapanContract manufacturer0000api.fda.gov
Biolis Medical Corp.Hino Tokyo, JapanManufacturer0000api.fda.gov
Canon Inc.OTAWARA-SHI Tochigi, JapanContract 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
DIAMOND DIAGNOSTICS IncHolliston, MA, United StatesManufacturer0000api.fda.gov
Diamond Diagnostics Inc.Budapest, HungaryContract manufacturer, Exporter to the US0000api.fda.gov
Edan Instruments, Inc.Shenzhen Guangdong, ChinaManufacturer0000api.fda.gov
Epocal, Inc.Ottawa Ontario, CanadaManufacturer, Specification developer0000api.fda.gov
Ever Pharma JenaJena Thuringia, GermanyContract manufacturer0000api.fda.gov
Epocal IncOttawa Ontario, CanadaManufacturer, Specification developer0000api.fda.gov
Furuno Electric Co., Ltd.NISHINOMIYA-CITY Hyogo, JapanManufacturer0000api.fda.gov
Fisher DiagnosticsMiddletown, VA, United StatesContract manufacturer0000api.fda.gov
Hitachi High-Tech Corp., Naka DivisionHitachinaka-shi Ibaraki, JapanContract manufacturer0000api.fda.gov
Horiba Abx SASMONTPELLIER Herault, FranceManufacturer, Specification developer0000api.fda.gov
Horiba Ltd.Kyoto, JapanContract manufacturer, Exporter to the US, Specification developer0000api.fda.gov
Inpeco S.P.A.Val della Torre Torino, ItalyContract manufacturer0000api.fda.gov
Inpeco SANovazzano Ticino, SwitzerlandExporter to the US, Specification developer0000api.fda.gov
Instrumentation Laboratory Co.Bedford, MA, United StatesManufacturer0000api.fda.gov
Instrumentation Laboratory Co.Orangeburg, NY, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
Jeol Ltd.Musashimurayama Tokyo, JapanManufacturer0000api.fda.gov
Nova Biomedical CorporationBillerica, MA, United StatesManufacturer, Manufacturer for export, Remanufacturer0000api.fda.gov
Nypro Inc. (Chicago)Gurnee, IL, United StatesContract manufacturer0000api.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
Randox Laboratories LimitedCRUMLIN, COUNTY ANTRIM Antrim and Newtownabbey, United KingdomManufacturer, Repackager or relabeler0000api.fda.gov
Randox Laboratories LimitedANTRIM, COUNTY ANTRIM Antrim and Newtownabbey, United KingdomManufacturer0000api.fda.gov
Roche Diagnostics GMBHMANNHEIM Baden-Wurttemberg, GermanyExporter to the US, Manufacturer, Repackager or relabeler, Specification developer0000api.fda.gov
Roche Diagnostics GMBHPENZBERG Bavaria, GermanyManufacturer0000api.fda.gov
Roche Diagnostics International Ltd.ROTKREUZ Zug, SwitzerlandManufacturer0000api.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
Sanzay Corporation -Miami Gardens, FL, United StatesRemanufacturer0000api.fda.gov
Scientific Supplies & Technology, Inc.Doral, FL, United StatesRemanufacturer, Repackager or relabeler0000api.fda.gov
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.Shenzhen Guangdong, ChinaManufacturer0000api.fda.gov
Siemens Healthcare Diagnostics Inc.Newark, DE, United StatesManufacturer, Specification developer0000api.fda.gov
Siemens Healthcare Diagnostics Manufacturing LtdSUDBURY Suffolk, United KingdomManufacturer, Specification developer0000api.fda.gov
Sekisui Diagnostics P.E.I. Inc.CHARLOTTETOWN Prince Edward Island, CanadaContract manufacturer0000api.fda.gov
Shenzhen Mindray Bio-Medical Electronics Co.,LTDSHENZHEN Guangdong, ChinaExporter to the US, Specification developer0000api.fda.gov
Siegfried Hameln GmbHHameln Lower Saxony, GermanyContract manufacturer0000api.fda.gov
Siemens Healthcare Diagnostics IncEast Walpole, MA, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Siemens Healthcare Diagnostics Inc.E Walpole, MA, United StatesManufacturer0000api.fda.gov
Siemens Healthcare Diagnostics Manufacturing Ltd.SWORDS Dublin(County), IrelandManufacturer0000api.fda.gov
Tessy Plastics Corp.Elbridge, NY, United StatesContract manufacturer0000api.fda.gov
VitalScientificSEES Normandie, FranceManufacturer0000api.fda.gov
VitalScientific B.V.SPANKEREN Gelderland, NetherlandsContract manufacturer, Manufacturer0000api.fda.gov

Updated October 30, 2018. 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.