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
| Country | Makers |
|---|---|
| United States | 14 |
| Ireland | 2 |
| France | 2 |
| Japan | 2 |
| Germany | 2 |
| Canada | 1 |
| Italy | 1 |
| Argentina | 1 |
| India | 1 |
| Greece | 1 |
| United Kingdom | 1 |
| Switzerland | 1 |
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.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Fisher Diagnostics | Middletown, VA, United States | Manufacturer | 2 | November 15, 1994 | 0 | 0 | 0 | api.fda.gov |
| Siemens Healthcare Diagnostics Inc. | Newark, DE, United States | Manufacturer, Specification developer | 2 | August 7, 2006 | 0 | 2 | 0 | api.fda.gov |
| Sekisui Diagnostics P.E.I. Inc. | CHARLOTTETOWN Prince Edward Island, Canada | Contract manufacturer, Manufacturer | 2 | May 14, 2002 | 0 | 0 | 0 | api.fda.gov |
| Beckman Coulter Ireland Inc | O CALLAGHANS MILLS Clare, Ireland | Contract manufacturer, Manufacturer | 1 | December 18, 1992 | 0 | 0 | 0 | api.fda.gov |
| Cliniqa Corporation | San Marcos, CA, United States | Manufacturer | 1 | February 12, 1987 | 0 | 0 | 0 | api.fda.gov |
| Horiba Instruments Incorporated | Canton, MI, United States | Manufacturer | 1 | January 21, 1987 | 0 | 1 | 0 | api.fda.gov |
| Ortho-Clinical Diagnostics, Inc. | Rochester, NY, United States | Complaint file establishment, Specification developer | 1 | February 4, 1991 | 0 | 1 | 0 | api.fda.gov |
| Ortho-Clinical Diagnostics, Inc. | Rochester, NY, United States | Manufacturer | 1 | February 4, 1991 | 0 | 0 | 0 | api.fda.gov |
| Sentinel CH. SPA | Milano, Italy | Manufacturer | 1 | August 25, 2005 | 0 | 1 | 0 | api.fda.gov |
| Teco Diagnostics | Anaheim, CA, United States | Manufacturer | 1 | May 17, 1990 | 0 | 0 | 0 | api.fda.gov |
| VitalScientific | SEES Normandie, France | Manufacturer | 1 | May 21, 2004 | 0 | 0 | 0 | api.fda.gov |
| Wiener Laboratorios S.A.I.C. | ROSARIO Santa Fe, Argentina | Manufacturer | 1 | November 13, 2001 | 0 | 0 | 0 | api.fda.gov |
| Abbott Ireland Diagnostics Division | Longford, Ireland | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Alfa Wassermann | West Caldwell, NJ, United States | Complaint file establishment, Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Beckman Coulter, Inc. | Brea, CA, United States | Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Beckman Coulter, Inc. | Carlsbad, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Bialex Lab | Wichita Falls, TX, United States | Manufacturer, Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov | |
| Beckman Coulter K. K. | Sunto-Gun Shizuoka, Japan | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Beckman Coulter Mishima K.K. | SUNTO-GUN Shizuoka, Japan | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Horiba Abx SAS | MONTPELLIER Herault, France | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Lords Mark Industries Ltd. | Daman and Diu Dadra and Nagar Haveli, India | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Medica Corp. | Bedford, MA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Medicon Hellas SA | GERAKAS Attiki, Greece | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Randox Laboratories Limited | CRUMLIN, COUNTY ANTRIM Antrim and Newtownabbey, United Kingdom | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Roche Diagnostics GMBH | MANNHEIM Baden-Wurttemberg, Germany | Exporter to the US, Manufacturer, Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Roche Diagnostics GMBH | PENZBERG Bavaria, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Roche Diagnostics International Ltd. | ROTKREUZ Zug, Switzerland | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Stanbio Laboratory | Boerne, TX, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Siemens Healthcare Diagnostics Inc. | Tarrytown, NY, United States | Complaint file establishment, Specification developer | 0 | 0 | 2 | 0 | api.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.