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Data / Medical devices / Photometric Method, Iron (Non-Heme)

Photometric Method, Iron (Non-Heme) (JIY): 29 FDA-registered makers in 12 countries

29 establishments in 12 countries are registered with the FDA to make Photometric Method, Iron (Non-Heme) (product code JIY, Class 1, 21 CFR 862.1410). 12 of them have a 510(k) clearance or PMA approval on file and 5 have a recall event. The FDA has issued 67 510(k) clearances under this code, the latest on August 7, 2006, and lists 10 recall events (0 Class I). FDA data exported November 2, 2026.

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Product code
JIY
Device class
1
Regulation
862.1410
Medical specialty
Clinical Chemistry

Makers by country

CountryMakers
United States14
Ireland2
France2
Japan2
Germany2
Canada1
Italy1
Argentina1
India1
Greece1
United Kingdom1
Switzerland1

Makers of Photometric Method, Iron (Non-Heme)

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
Fisher DiagnosticsMiddletown, VA, United StatesManufacturer2November 15, 1994000api.fda.gov
Siemens Healthcare Diagnostics Inc.Newark, DE, United StatesManufacturer, Specification developer2August 7, 2006020api.fda.gov
Sekisui Diagnostics P.E.I. Inc.CHARLOTTETOWN Prince Edward Island, CanadaContract manufacturer, Manufacturer2May 14, 2002000api.fda.gov
Beckman Coulter Ireland IncO CALLAGHANS MILLS Clare, IrelandContract manufacturer, Manufacturer1December 18, 1992000api.fda.gov
Cliniqa CorporationSan Marcos, CA, United StatesManufacturer1February 12, 1987000api.fda.gov
Horiba Instruments IncorporatedCanton, MI, United StatesManufacturer1January 21, 1987010api.fda.gov
Ortho-Clinical Diagnostics, Inc.Rochester, NY, United StatesComplaint file establishment, Specification developer1February 4, 1991010api.fda.gov
Ortho-Clinical Diagnostics, Inc.Rochester, NY, United StatesManufacturer1February 4, 1991000api.fda.gov
Sentinel CH. SPAMilano, ItalyManufacturer1August 25, 2005010api.fda.gov
Teco DiagnosticsAnaheim, CA, United StatesManufacturer1May 17, 1990000api.fda.gov
VitalScientificSEES Normandie, FranceManufacturer1May 21, 2004000api.fda.gov
Wiener Laboratorios S.A.I.C.ROSARIO Santa Fe, ArgentinaManufacturer1November 13, 2001000api.fda.gov
Abbott Ireland Diagnostics DivisionLongford, IrelandManufacturer0000api.fda.gov
Alfa WassermannWest Caldwell, NJ, United StatesComplaint file establishment, Repackager or relabeler, Specification developer0000api.fda.gov
Beckman Coulter, Inc.Brea, CA, United StatesManufacturer, Specification developer0000api.fda.gov
Beckman Coulter, Inc.Carlsbad, CA, United StatesContract manufacturer0000api.fda.gov
Bialex LabWichita Falls, TX, United StatesManufacturer, Manufacturer for export0000api.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
Horiba Abx SASMONTPELLIER Herault, FranceSpecification developer0000api.fda.gov
Lords Mark Industries Ltd.Daman and Diu Dadra and Nagar Haveli, IndiaManufacturer0000api.fda.gov
Medica Corp.Bedford, MA, United StatesManufacturer0000api.fda.gov
Medicon Hellas SAGERAKAS Attiki, GreeceManufacturer0000api.fda.gov
Randox Laboratories LimitedCRUMLIN, COUNTY ANTRIM Antrim and Newtownabbey, United KingdomContract manufacturer0000api.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
Stanbio LaboratoryBoerne, TX, United StatesManufacturer0000api.fda.gov
Siemens Healthcare Diagnostics Inc.Tarrytown, NY, United StatesComplaint file establishment, Specification developer0020api.fda.gov

Updated August 7, 2006. 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.