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
| Country | Makers |
|---|---|
| United States | 20 |
| Japan | 4 |
| United Kingdom | 2 |
| Germany | 2 |
| France | 2 |
| Canada | 1 |
| Ireland | 1 |
| Argentina | 1 |
| Switzerland | 1 |
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.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Abbott Laboratories | Irving, TX, United States | Specification developer | 2 | September 12, 2018 | 0 | 0 | 0 | api.fda.gov |
| Randox Laboratories Limited | CRUMLIN, COUNTY ANTRIM Antrim and Newtownabbey, United Kingdom | Contract manufacturer, Manufacturer | 2 | April 28, 2017 | 0 | 0 | 0 | api.fda.gov |
| Sekisui Diagnostics P.E.I. Inc. | CHARLOTTETOWN Prince Edward Island, Canada | Contract manufacturer, Manufacturer | 2 | December 2, 2011 | 0 | 0 | 0 | api.fda.gov |
| Abaxis, Inc. | Union City, CA, United States | Manufacturer | 1 | January 30, 2004 | 0 | 0 | 0 | api.fda.gov |
| Alfa Wassermann | West Caldwell, NJ, United States | Complaint file establishment, Repackager or relabeler, Specification developer | 1 | August 27, 2012 | 0 | 0 | 0 | api.fda.gov |
| Beckman Coulter, Inc. | Brea, CA, United States | Manufacturer, Specification developer | 1 | January 27, 1989 | 0 | 1 | 0 | api.fda.gov |
| Beckman Coulter Ireland Inc | O CALLAGHANS MILLS Clare, Ireland | Contract manufacturer, Manufacturer | 1 | December 27, 1994 | 0 | 0 | 0 | api.fda.gov |
| Cliniqa Corporation | San Marcos, CA, United States | Manufacturer | 1 | January 21, 1988 | 0 | 0 | 0 | api.fda.gov |
| Fisher Diagnostics | Middletown, VA, United States | Contract manufacturer, Manufacturer | 1 | March 11, 1992 | 0 | 0 | 0 | api.fda.gov |
| Horiba Instruments Incorporated | Canton, MI, United States | Manufacturer | 1 | September 16, 1985 | 0 | 0 | 0 | api.fda.gov |
| Infrared Laboratory Systems dba SYNERMED | Westfield, IN, United States | Manufacturer | 1 | July 31, 1990 | 0 | 0 | 0 | api.fda.gov |
| Roche Diagnostics GMBH | MANNHEIM Baden-Wurttemberg, Germany | Exporter to the US, Manufacturer, Repackager or relabeler, Specification developer | 1 | October 21, 1998 | 0 | 0 | 0 | api.fda.gov |
| Stanbio Laboratory | Boerne, TX, United States | Manufacturer | 1 | February 7, 1989 | 0 | 0 | 0 | api.fda.gov |
| Siemens Healthcare Diagnostics Inc. | Tarrytown, NY, United States | Complaint file establishment, Specification developer | 1 | January 19, 2017 | 0 | 0 | 0 | api.fda.gov |
| Teco Diagnostics | Anaheim, CA, United States | Manufacturer | 1 | December 18, 1987 | 0 | 0 | 0 | api.fda.gov |
| VitalScientific | SEES Normandie, France | Manufacturer | 1 | March 8, 2004 | 0 | 0 | 0 | api.fda.gov |
| Wiener Laboratorios S.A.I.C. | ROSARIO Santa Fe, Argentina | Manufacturer | 1 | November 8, 2001 | 0 | 0 | 0 | api.fda.gov |
| Beckman Coulter, Inc. | Carlsbad, CA, United States | Contract manufacturer | 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 | |
| Furuno Electric Co., Ltd. | NISHINOMIYA-CITY Hyogo, Japan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Horiba Abx SAS | MONTPELLIER Herault, France | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| High Technology, Inc. | North Attleboro, MA, United States | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Medica Corp. | Bedford, MA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Microgenics Corporation | Fremont, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Nittobo Medical Co., Ltd. Medical Development Center | Koriyama Fukushima, Japan | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ortho-Clinical Diagnostics, Inc. | Rochester, NY, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ortho-Clinical Diagnostics, Inc. | Rochester, NY, United States | Complaint file establishment, Specification developer | 0 | 0 | 1 | 0 | api.fda.gov | |
| Ortho-Clinical Diagnostics, Inc. | Rochester, NY, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Randox Laboratories Limited | ANTRIM, COUNTY ANTRIM Antrim and Newtownabbey, United Kingdom | Manufacturer | 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 | |
| Siemens Healthcare Diagnostics Inc. | Newark, DE, United States | Manufacturer, Specification developer | 0 | 0 | 5 | 0 | api.fda.gov | |
| Viant AS&O Holdings, LLC | Brimfield, MA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.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.