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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

CountryMakers
United States27
China18
South Korea6
Taiwan6
United Kingdom3
Germany3
Switzerland2
Poland2
Japan2
Jordan1
Hong Kong1
Ireland1
Mexico1
Argentina1

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.

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
I-SENS Songdo Factory 2lncheon Incheon, South KoreaManufacturer2September 9, 2020000api.fda.gov
I-Sens, Inc.Seoul, South KoreaSpecification developer2September 9, 2020000api.fda.gov
i-SENS Wonju FactoryWonju-si Gangwon, South KoreaManufacturer2September 9, 2020000api.fda.gov
Abbott Diabetes Care Inc.Alameda, CA, United StatesComplaint file establishment, Specification developer1April 21, 2006010api.fda.gov
Abbott Diabetes Care LimitedWITNEY OXON Oxfordshire, United KingdomManufacturer1April 21, 2006000api.fda.gov
Acon Laboratories, Inc.San Diego, CA, United StatesManufacturer, Specification developer1July 6, 2017000api.fda.gov
Ascensia Diabetes Care Holdings AGBasel Basel-Stadt, SwitzerlandSpecification developer1July 8, 1980000api.fda.gov
Ascensia Diabetes Care Poland Sp. z o.o.Warszawa Mazowieckie, PolandSpecification developer1July 8, 1980000api.fda.gov
Ascensia Diabetes Care US Inc.Parsippany, NJ, United StatesSpecification developer1July 8, 1980000api.fda.gov
Chong Qing Teco Huayi Pharm. Co.Shapingba Dist., Chongqing, ChinaManufacturer1April 26, 2001000api.fda.gov
Stanbio LaboratoryBoerne, TX, United StatesManufacturer, Repackager or relabeler1March 4, 1991020api.fda.gov
Teco DiagnosticsAnaheim, CA, United StatesManufacturer1April 26, 2001000api.fda.gov
Vivachek Biotech (hangzhou) Co., LtdHangzhou, Zhuji Zhejiang, ChinaManufacturer1June 5, 2020000api.fda.gov
Aceso Laboratories Inc.Chino, CA, United StatesManufacturer0000api.fda.gov
Acon Biotech (hangzhou) Co., Ltd.HANGZHOU Zhejiang, ChinaContract manufacturer0000api.fda.gov
Apex Biotechnology Corp.HSINCHU Hsinchu(County), TaiwanExporter to the US, Manufacturer0000api.fda.gov
ARKRAY Factory, Inc.Koka-shi Shiga, JapanManufacturer0000api.fda.gov
Arkray, Inc.Kamigyo-ku Kyoto, JapanSpecification developer0000api.fda.gov
Assure Tech. (hangzhou) Co., Ltd.Hangzhou Zhejiang, ChinaComplaint file establishment, Manufacturer0000api.fda.gov
Atlas MedicalAmman Al 'Asimah, JordanManufacturer0000api.fda.gov
Ave Science & Technology Co., LtdChangsha Hunan, ChinaExporter to the US, Manufacturer0000api.fda.gov
Assure Tech. (Hangzhou) Co., Ltd.Hangzhou Zhejiang, ChinaManufacturer0000api.fda.gov
AusMed Global LimitedHong Kong, Hong KongManufacturer0000api.fda.gov
B&e Bio-Technology Co., Ltd.Yantai Shandong, ChinaManufacturer0000api.fda.gov
Beckman Coulter, Inc.Chaska, MN, United StatesContract manufacturer0000api.fda.gov
Beckman Coulter, Inc.Miami, FL, United StatesSpecification developer0000api.fda.gov
Biorex Labs LLCBroadview Heights, OH, United StatesManufacturer, Specification developer0000api.fda.gov
Beckman Coulter Ireland IncO CALLAGHANS MILLS Clare, IrelandContract manufacturer0000api.fda.gov
Changchun Merydi Bio-Tech Co., Ltd.changchun Jilin, ChinaManufacturer0000api.fda.gov
Changchun Wancheng Bio-Electron Co., Ltd.Changchun Jilin, ChinaManufacturer0010api.fda.gov
Chungdo Pharm. Co., Ltd.Chuncheon-si Gangwon, South KoreaContract manufacturer, Manufacturer0000api.fda.gov
Changchun LYZ Technology Co.,LTDChangchun City Jilin, ChinaExporter to the US, Manufacturer0000api.fda.gov
Dfi Co., Ltd.Gimhae Jeonnam, South KoreaManufacturer0010api.fda.gov
Diasys Diagnostic Systems GMBHHolzheim Rhineland-Palatinate, GermanyContract manufacturer, Manufacturer0000api.fda.gov
Dirui Industrial Co., Ltd.CHANGCHUN Jilin, ChinaContract manufacturer, Manufacturer0000api.fda.gov
Diagnostic Automation/ Cortez Diagnostics Inc,.Woodland Hills, CA, United StatesManufacturer0000api.fda.gov
Diazyme Laboratories, Inc.Poway, CA, United StatesManufacturer0000api.fda.gov
E-Linkcare Meditech Co., Ltd.Taizhou Zhejiang, ChinaManufacturer0000api.fda.gov
Eaglenos Sciences, Inc.Nanjing Jiangsu, ChinaManufacturer0000api.fda.gov
Fisher DiagnosticsMiddletown, VA, United StatesContract manufacturer0000api.fda.gov
Flextronics Manufacturing Aguascalientes, S.A de C.VAguascalientes, MexicoContract manufacturer0000api.fda.gov
General Life Biotechnology Co., Ltd.New Taipei City, TaiwanManufacturer0000api.fda.gov
Germaine Laboratories, Inc.San Antonio, TX, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
Global Instrumentation Corp.New Taipei, TaiwanContract manufacturer0000api.fda.gov
Healgen Scientific LLCHouston, TX, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Jilin Hongyi Bio-Tech Co., Ltd.Changchun Jilin, ChinaExporter to the US, Manufacturer0000api.fda.gov
Jilin Test Bio-Electron Co.,ltdChangchun Jilin, ChinaManufacturer0000api.fda.gov
Kimball Electronics Poland Sp.z o.oTarnowo Podgorne Wielkopolskie, PolandContract manufacturer0000api.fda.gov
Macherey-Nagel GMBH & Co., KG.DUEREN North Rhine-Westphalia, GermanyContract manufacturer0000api.fda.gov
Mediusa Inc.Los Angeles, CA, United StatesRemanufacturer, Repackager or relabeler0000api.fda.gov
Nova Biomedical CorporationWaltham, MA, United StatesContract manufacturer, Manufacturer, Manufacturer for export, Specification developer0000api.fda.gov
Nova Biomedical Corporation Diabetes ProductsBillerica, MA, United StatesComplaint file establishment, Contract manufacturer, Manufacturer, Manufacturer for export0000api.fda.gov
Nova Biomedical CorporationBillerica, MA, United StatesContract manufacturer, Manufacturer, Manufacturer for export0000api.fda.gov
Randox Laboratories LimitedCRUMLIN, COUNTY ANTRIM Antrim and Newtownabbey, United KingdomManufacturer0000api.fda.gov
Rasimo Systems LLCRaleigh, NC, United StatesSpecification developer0000api.fda.gov
Roche Diagnostics GMBHMANNHEIM Baden-Wurttemberg, GermanyExporter to the US, Manufacturer0000api.fda.gov
Roche Diagnostics International Ltd.ROTKREUZ Zug, SwitzerlandManufacturer0000api.fda.gov
RR Donnelley-Supply Chain SolutionsPlover, WI, United StatesContract manufacturer, Repackager or relabeler0000api.fda.gov
San Non Biotechnology Co., Ltd.New Taipei City, TaiwanContract manufacturer, Manufacturer0000api.fda.gov
Scientific Supplies & Technology, Inc.Doral, FL, United StatesRemanufacturer, Repackager or relabeler0000api.fda.gov
Siemens Healthcare Diagnostics Manufacturing LtdSUDBURY Suffolk, United KingdomManufacturer0000api.fda.gov
Siemens Healthcare Diagnostics IncEast Walpole, MA, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Siemens Healthcare Diagnostics Inc.Tarrytown, NY, United StatesSpecification developer0000api.fda.gov
Siemens Healthcare Diagnostics, Inc.Mishawaka, IN, United StatesManufacturer0000api.fda.gov
Sysmex America, Inc.Buffalo Grove, IL, United StatesContract manufacturer0000api.fda.gov
Sysmex America, Inc. - Vernon HillsVernon Hills, IL, United StatesContract manufacturer0000api.fda.gov
Taidoc Technology CorporationNew Taipei City, TaiwanManufacturer0000api.fda.gov
Trividia Health, Inc.Fort Lauderdale, FL, United StatesComplaint file establishment, Manufacturer0000api.fda.gov
URIT Medical Electronic Co., Ltd.Guilin Guangxi, ChinaContract manufacturer, Manufacturer0000api.fda.gov
Visgeneer, Inc.HSINCHU CITY Hsinchu(City), TaiwanContract manufacturer, Manufacturer0000api.fda.gov
Wiener Laboratorios S.A.I.C.ROSARIO Santa Fe, ArgentinaManufacturer0000api.fda.gov
Weihai Kangzheng Medical Equipments Technology Co.,Ltdweihai Shandong, ChinaContract manufacturer, Manufacturer0000api.fda.gov
Yd DiagnosticsYongin-si Gyeonggi, South KoreaManufacturer0000api.fda.gov
Zhejiang Orient Gene BiotechHuzhou Zhejiang, ChinaContract manufacturer, Manufacturer0000api.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.