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Data / Medical devices / Ferrozine (Colorimetric) Iron Binding Capacity

Ferrozine (Colorimetric) Iron Binding Capacity (JMO): 28 FDA-registered makers in 11 countries

28 establishments in 11 countries are registered with the FDA to make Ferrozine (Colorimetric) Iron Binding Capacity (product code JMO, Class 1, 21 CFR 862.1415). 12 of them have a 510(k) clearance or PMA approval on file and 5 have a recall event. The FDA has issued 46 510(k) clearances under this code, the latest on June 1, 2012, and lists 7 recall events (0 Class I). FDA data exported November 2, 2026.

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Product code
JMO
Device class
1
Regulation
862.1415
Medical specialty
Clinical Chemistry

Makers by country

CountryMakers
United States14
Japan3
China2
Germany2
Ireland1
United Kingdom1
Canada1
Argentina1
India1
Greece1
Switzerland1

Makers of Ferrozine (Colorimetric) Iron Binding Capacity

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
Ortho-Clinical Diagnostics, Inc.Rochester, NY, United StatesManufacturer, Repackager or relabeler2June 15, 2006010api.fda.gov
Ortho-Clinical Diagnostics, Inc.Rochester, NY, United StatesComplaint file establishment, Specification developer2June 15, 2006010api.fda.gov
Siemens Healthcare Diagnostics Inc.Newark, DE, United StatesManufacturer, Specification developer2May 2, 2000020api.fda.gov
Alfa WassermannWest Caldwell, NJ, United StatesComplaint file establishment, Repackager or relabeler, Specification developer1June 1, 2012000api.fda.gov
Beckman Coulter, Inc.Brea, CA, United StatesSpecification developer1May 10, 1996020api.fda.gov
Beckman Coulter Ireland IncO CALLAGHANS MILLS Clare, IrelandManufacturer1July 16, 2004000api.fda.gov
Fisher DiagnosticsMiddletown, VA, United StatesContract manufacturer, Manufacturer1May 2, 2000000api.fda.gov
Infrared Laboratory Systems dba SYNERMEDWestfield, IN, United StatesManufacturer1July 21, 1992000api.fda.gov
Randox Laboratories LimitedCRUMLIN, COUNTY ANTRIM Antrim and Newtownabbey, United KingdomContract manufacturer, Manufacturer1January 6, 1998000api.fda.gov
Sekisui Diagnostics P.E.I. Inc.CHARLOTTETOWN Prince Edward Island, CanadaContract manufacturer, Manufacturer1August 20, 1996010api.fda.gov
Siemens Healthcare Diagnostics Inc.Tarrytown, NY, United StatesComplaint file establishment, Specification developer1May 2, 2000000api.fda.gov
Wiener Laboratorios S.A.I.C.ROSARIO Santa Fe, ArgentinaManufacturer1November 13, 2001000api.fda.gov
Beckman Coulter, Inc.Carlsbad, CA, United StatesContract manufacturer0000api.fda.gov
Bialex LabWichita Falls, TX, United StatesManufacturer0000api.fda.gov
Biobase Biodustry(shandong)co., LtdJinan Shandong, ChinaManufacturer0000api.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
Dirui Industrial Co., Ltd.CHANGCHUN Jilin, ChinaManufacturer0000api.fda.gov
High Technology, Inc.North Attleboro, MA, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
Kamiya Biomedical Company LLCTukwila, WA, United StatesManufacturer0000api.fda.gov
Lords Mark Industries Ltd.Daman and Diu Dadra and Nagar Haveli, IndiaManufacturer0000api.fda.gov
Medicon Hellas SAGERAKAS Attiki, GreeceManufacturer0000api.fda.gov
Microgenics CorporationFremont, CA, United StatesContract manufacturer0000api.fda.gov
Nittobo Medical Co., Ltd. Medical Development CenterKoriyama Fukushima, JapanContract 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
Teco DiagnosticsAnaheim, CA, United StatesManufacturer0000api.fda.gov

Updated June 1, 2012. 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.