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Data / Medical devices / Photometric Method, Magnesium

Photometric Method, Magnesium (JGJ): 34 FDA-registered makers in 9 countries

34 establishments in 9 countries are registered with the FDA to make Photometric Method, Magnesium (product code JGJ, Class 1, 21 CFR 862.1495). 17 of them have a 510(k) clearance or PMA approval on file and 3 have a recall event. The FDA has issued 90 510(k) clearances under this code, the latest on September 12, 2018, and lists 12 recall events (0 Class I). FDA data exported November 2, 2026.

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Product code
JGJ
Device class
1
Regulation
862.1495
Medical specialty
Clinical Chemistry

Makers by country

CountryMakers
United States20
Japan4
United Kingdom2
Germany2
France2
Canada1
Ireland1
Argentina1
Switzerland1

Makers of Photometric Method, Magnesium

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 StatesSpecification developer2September 12, 2018000api.fda.gov
Randox Laboratories LimitedCRUMLIN, COUNTY ANTRIM Antrim and Newtownabbey, United KingdomContract manufacturer, Manufacturer2April 28, 2017000api.fda.gov
Sekisui Diagnostics P.E.I. Inc.CHARLOTTETOWN Prince Edward Island, CanadaContract manufacturer, Manufacturer2December 2, 2011000api.fda.gov
Abaxis, Inc.Union City, CA, United StatesManufacturer1January 30, 2004000api.fda.gov
Alfa WassermannWest Caldwell, NJ, United StatesComplaint file establishment, Repackager or relabeler, Specification developer1August 27, 2012000api.fda.gov
Beckman Coulter, Inc.Brea, CA, United StatesManufacturer, Specification developer1January 27, 1989010api.fda.gov
Beckman Coulter Ireland IncO CALLAGHANS MILLS Clare, IrelandContract manufacturer, Manufacturer1December 27, 1994000api.fda.gov
Cliniqa CorporationSan Marcos, CA, United StatesManufacturer1January 21, 1988000api.fda.gov
Fisher DiagnosticsMiddletown, VA, United StatesContract manufacturer, Manufacturer1March 11, 1992000api.fda.gov
Horiba Instruments IncorporatedCanton, MI, United StatesManufacturer1September 16, 1985000api.fda.gov
Infrared Laboratory Systems dba SYNERMEDWestfield, IN, United StatesManufacturer1July 31, 1990000api.fda.gov
Roche Diagnostics GMBHMANNHEIM Baden-Wurttemberg, GermanyExporter to the US, Manufacturer, Repackager or relabeler, Specification developer1October 21, 1998000api.fda.gov
Stanbio LaboratoryBoerne, TX, United StatesManufacturer1February 7, 1989000api.fda.gov
Siemens Healthcare Diagnostics Inc.Tarrytown, NY, United StatesComplaint file establishment, Specification developer1January 19, 2017000api.fda.gov
Teco DiagnosticsAnaheim, CA, United StatesManufacturer1December 18, 1987000api.fda.gov
VitalScientificSEES Normandie, FranceManufacturer1March 8, 2004000api.fda.gov
Wiener Laboratorios S.A.I.C.ROSARIO Santa Fe, ArgentinaManufacturer1November 8, 2001000api.fda.gov
Beckman Coulter, Inc.Carlsbad, CA, United StatesContract manufacturer0000api.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
Furuno Electric Co., Ltd.NISHINOMIYA-CITY Hyogo, JapanManufacturer0000api.fda.gov
Horiba Abx SASMONTPELLIER Herault, FranceSpecification developer0000api.fda.gov
High Technology, Inc.North Attleboro, MA, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
Medica Corp.Bedford, MA, United StatesManufacturer0000api.fda.gov
Microgenics CorporationFremont, CA, United StatesContract manufacturer0000api.fda.gov
Nittobo Medical Co., Ltd. Medical Development CenterKoriyama Fukushima, JapanContract manufacturer0000api.fda.gov
Ortho-Clinical Diagnostics, Inc.Rochester, NY, United StatesManufacturer0000api.fda.gov
Ortho-Clinical Diagnostics, Inc.Rochester, NY, United StatesComplaint file establishment, Specification developer0010api.fda.gov
Ortho-Clinical Diagnostics, Inc.Rochester, NY, United StatesManufacturer0000api.fda.gov
Randox Laboratories LimitedANTRIM, COUNTY ANTRIM Antrim and Newtownabbey, United KingdomManufacturer0000api.fda.gov
Roche Diagnostics GMBHPENZBERG Bavaria, GermanyManufacturer0000api.fda.gov
Roche Diagnostics International Ltd.ROTKREUZ Zug, SwitzerlandManufacturer0000api.fda.gov
Siemens Healthcare Diagnostics Inc.Newark, DE, United StatesManufacturer, Specification developer0050api.fda.gov
Viant AS&O Holdings, LLCBrimfield, MA, United StatesContract manufacturer0000api.fda.gov

Updated September 12, 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.