Data / Medical devices / Nitroprusside, Ketones (Urinary, Non-Quant.)
Nitroprusside, Ketones (Urinary, Non-Quant.) (JIN): 74 FDA-registered makers in 14 countries
74 establishments in 14 countries are registered with the FDA to make Nitroprusside, Ketones (Urinary, Non-Quant.) (product code JIN, Class 1, 21 CFR 862.1435). 13 of them have a 510(k) clearance or PMA approval on file and 4 have a recall event. The FDA has issued 24 510(k) clearances under this code, the latest on September 9, 2020, and lists 9 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- JIN
- Device class
- 1
- Regulation
- 862.1435
- Medical specialty
- Clinical Chemistry
Makers by country
| Country | Makers |
|---|---|
| United States | 27 |
| China | 18 |
| South Korea | 6 |
| Taiwan | 6 |
| United Kingdom | 3 |
| Germany | 3 |
| Switzerland | 2 |
| Poland | 2 |
| Japan | 2 |
| Jordan | 1 |
| Hong Kong | 1 |
| Ireland | 1 |
| Mexico | 1 |
| Argentina | 1 |
Makers of Nitroprusside, Ketones (Urinary, Non-Quant.)
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 |
|---|---|---|---|---|---|---|---|---|
| I-SENS Songdo Factory 2 | lncheon Incheon, South Korea | Manufacturer | 2 | September 9, 2020 | 0 | 0 | 0 | api.fda.gov |
| I-Sens, Inc. | Seoul, South Korea | Specification developer | 2 | September 9, 2020 | 0 | 0 | 0 | api.fda.gov |
| i-SENS Wonju Factory | Wonju-si Gangwon, South Korea | Manufacturer | 2 | September 9, 2020 | 0 | 0 | 0 | api.fda.gov |
| Abbott Diabetes Care Inc. | Alameda, CA, United States | Complaint file establishment, Specification developer | 1 | April 21, 2006 | 0 | 1 | 0 | api.fda.gov |
| Abbott Diabetes Care Limited | WITNEY OXON Oxfordshire, United Kingdom | Manufacturer | 1 | April 21, 2006 | 0 | 0 | 0 | api.fda.gov |
| Acon Laboratories, Inc. | San Diego, CA, United States | Manufacturer, Specification developer | 1 | July 6, 2017 | 0 | 0 | 0 | api.fda.gov |
| Ascensia Diabetes Care Holdings AG | Basel Basel-Stadt, Switzerland | Specification developer | 1 | July 8, 1980 | 0 | 0 | 0 | api.fda.gov |
| Ascensia Diabetes Care Poland Sp. z o.o. | Warszawa Mazowieckie, Poland | Specification developer | 1 | July 8, 1980 | 0 | 0 | 0 | api.fda.gov |
| Ascensia Diabetes Care US Inc. | Parsippany, NJ, United States | Specification developer | 1 | July 8, 1980 | 0 | 0 | 0 | api.fda.gov |
| Chong Qing Teco Huayi Pharm. Co. | Shapingba Dist., Chongqing, China | Manufacturer | 1 | April 26, 2001 | 0 | 0 | 0 | api.fda.gov |
| Stanbio Laboratory | Boerne, TX, United States | Manufacturer, Repackager or relabeler | 1 | March 4, 1991 | 0 | 2 | 0 | api.fda.gov |
| Teco Diagnostics | Anaheim, CA, United States | Manufacturer | 1 | April 26, 2001 | 0 | 0 | 0 | api.fda.gov |
| Vivachek Biotech (hangzhou) Co., Ltd | Hangzhou, Zhuji Zhejiang, China | Manufacturer | 1 | June 5, 2020 | 0 | 0 | 0 | api.fda.gov |
| Aceso Laboratories Inc. | Chino, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Acon Biotech (hangzhou) Co., Ltd. | HANGZHOU Zhejiang, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Apex Biotechnology Corp. | HSINCHU Hsinchu(County), Taiwan | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| ARKRAY Factory, Inc. | Koka-shi Shiga, Japan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Arkray, Inc. | Kamigyo-ku Kyoto, Japan | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Assure Tech. (hangzhou) Co., Ltd. | Hangzhou Zhejiang, China | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Atlas Medical | Amman Al 'Asimah, Jordan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ave Science & Technology Co., Ltd | Changsha Hunan, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Assure Tech. (Hangzhou) Co., Ltd. | Hangzhou Zhejiang, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| AusMed Global Limited | Hong Kong, Hong Kong | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| B&e Bio-Technology Co., Ltd. | Yantai Shandong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Beckman Coulter, Inc. | Chaska, MN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Beckman Coulter, Inc. | Miami, FL, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Biorex Labs LLC | Broadview Heights, OH, United States | Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Beckman Coulter Ireland Inc | O CALLAGHANS MILLS Clare, Ireland | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Changchun Merydi Bio-Tech Co., Ltd. | changchun Jilin, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Changchun Wancheng Bio-Electron Co., Ltd. | Changchun Jilin, China | Manufacturer | 0 | 0 | 1 | 0 | api.fda.gov | |
| Chungdo Pharm. Co., Ltd. | Chuncheon-si Gangwon, South Korea | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Changchun LYZ Technology Co.,LTD | Changchun City Jilin, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dfi Co., Ltd. | Gimhae Jeonnam, South Korea | Manufacturer | 0 | 0 | 1 | 0 | api.fda.gov | |
| Diasys Diagnostic Systems GMBH | Holzheim Rhineland-Palatinate, Germany | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dirui Industrial Co., Ltd. | CHANGCHUN Jilin, China | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Diagnostic Automation/ Cortez Diagnostics Inc,. | Woodland Hills, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Diazyme Laboratories, Inc. | Poway, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| E-Linkcare Meditech Co., Ltd. | Taizhou Zhejiang, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Eaglenos Sciences, Inc. | Nanjing Jiangsu, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Fisher Diagnostics | Middletown, VA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Flextronics Manufacturing Aguascalientes, S.A de C.V | Aguascalientes, Mexico | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| General Life Biotechnology Co., Ltd. | New Taipei City, Taiwan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Germaine Laboratories, Inc. | San Antonio, TX, United States | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Global Instrumentation Corp. | New Taipei, Taiwan | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Healgen Scientific LLC | Houston, TX, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jilin Hongyi Bio-Tech Co., Ltd. | Changchun Jilin, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jilin Test Bio-Electron Co.,ltd | Changchun Jilin, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Kimball Electronics Poland Sp.z o.o | Tarnowo Podgorne Wielkopolskie, Poland | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Macherey-Nagel GMBH & Co., KG. | DUEREN North Rhine-Westphalia, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Mediusa Inc. | Los Angeles, CA, United States | Remanufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Nova Biomedical Corporation | Waltham, MA, United States | Contract manufacturer, Manufacturer, Manufacturer for export, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Nova Biomedical Corporation Diabetes Products | Billerica, MA, United States | Complaint file establishment, Contract manufacturer, Manufacturer, Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov | |
| Nova Biomedical Corporation | Billerica, MA, United States | Contract manufacturer, Manufacturer, Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov | |
| Randox Laboratories Limited | CRUMLIN, COUNTY ANTRIM Antrim and Newtownabbey, United Kingdom | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Rasimo Systems LLC | Raleigh, NC, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Roche Diagnostics GMBH | MANNHEIM Baden-Wurttemberg, Germany | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Roche Diagnostics International Ltd. | ROTKREUZ Zug, Switzerland | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| RR Donnelley-Supply Chain Solutions | Plover, WI, United States | Contract manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| San Non Biotechnology Co., Ltd. | New Taipei City, Taiwan | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Scientific Supplies & Technology, Inc. | Doral, FL, United States | Remanufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Siemens Healthcare Diagnostics Manufacturing Ltd | SUDBURY Suffolk, United Kingdom | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Siemens Healthcare Diagnostics Inc | East Walpole, MA, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Siemens Healthcare Diagnostics Inc. | Tarrytown, NY, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Siemens Healthcare Diagnostics, Inc. | Mishawaka, IN, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Sysmex America, Inc. | Buffalo Grove, IL, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Sysmex America, Inc. - Vernon Hills | Vernon Hills, IL, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Taidoc Technology Corporation | New Taipei City, Taiwan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Trividia Health, Inc. | Fort Lauderdale, FL, United States | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| URIT Medical Electronic Co., Ltd. | Guilin Guangxi, China | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Visgeneer, Inc. | HSINCHU CITY Hsinchu(City), Taiwan | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Wiener Laboratorios S.A.I.C. | ROSARIO Santa Fe, Argentina | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Weihai Kangzheng Medical Equipments Technology Co.,Ltd | weihai Shandong, China | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Yd Diagnostics | Yongin-si Gyeonggi, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Zhejiang Orient Gene Biotech | Huzhou Zhejiang, China | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated September 9, 2020. 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.