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Data / Medical devices / Detergent

Detergent (JCB): 35 FDA-registered makers in 12 countries

35 establishments in 12 countries are registered with the FDA to make Detergent (product code JCB, Class 1, 21 CFR 864.4010). 0 of them have a 510(k) clearance or PMA approval on file and 1 has a recall event. The FDA has issued 0 510(k) clearances under this code, and lists 2 recall events (0 Class I). FDA data exported November 2, 2026.

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Product code
JCB
Device class
1
Regulation
864.4010
Medical specialty
Pathology

Makers by country

CountryMakers
United States16
China6
Italy3
Germany2
Poland1
Sweden1
Spain1
Hungary1
Canada1
Turkey1
Austria1
Finland1

Makers of Detergent

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
Abbott LaboratoriesIrving, TX, United StatesSpecification developer0000api.fda.gov
Avantor Performance Materials Poland S.A.Gliwice Slaskie, PolandContract manufacturer0000api.fda.gov
B&e Bio-Technology Co., Ltd.Yantai Shandong, ChinaManufacturer0000api.fda.gov
Beckman Coulter, Inc.Carlsbad, CA, United StatesContract manufacturer0000api.fda.gov
Beckman Coulter, Inc.Hialeah, FL, United StatesContract manufacturer0000api.fda.gov
Beckman Coulter, Inc.Miami, FL, United StatesSpecification developer0000api.fda.gov
Boule Medical ABSpanga Stockholm, SwedenExporter to the US, Specification developer0000api.fda.gov
Beckman Coulter GmbHKrefeld North Rhine-Westphalia, GermanyContract manufacturer0000api.fda.gov
Beckman Coulter, Inc.Hebron, KY, United StatesContract manufacturer0000api.fda.gov
Clinical Diagnostic Solutions, Inc.Plantation, FL, United StatesContract manufacturer, Manufacturer0000api.fda.gov
Copan ItaliaBRESCIA Lombardy, ItalyContract manufacturer0000api.fda.gov
Carolina Liquid ChemistriesBrea, CA, United StatesManufacturer0000api.fda.gov
Copan WASPBrescia Lombardy, ItalySpecification developer0000api.fda.gov
Diagnostic Grifols, S.A.PARETS DEL VALLES Barcelona, SpainManufacturer, Specification developer0000api.fda.gov
Dirui Industrial Co., Ltd.CHANGCHUN Jilin, ChinaManufacturer0000api.fda.gov
Diatron MI PlcBudapest, HungaryManufacturer0000api.fda.gov
Fisher DiagnosticsMiddletown, VA, United StatesContract manufacturer0000api.fda.gov
Germiphene Corp.BRANTFORD Ontario, CanadaManufacturer0000api.fda.gov
High Technology, Inc.North Attleboro, MA, United StatesManufacturer0000api.fda.gov
Infitek Co., Ltd.Shanghai, ChinaManufacturer0000api.fda.gov
JAS Diagnostics/Drew ScientificPlantation, FL, United StatesManufacturer0000api.fda.gov
Medical Chemical CorporationTorrance, CA, United StatesManufacturer0000api.fda.gov
MicroCare MedicalCommerce City, CO, United StatesManufacturer0010api.fda.gov
Phoenix Diagnostics, Inc.Natick, MA, United StatesManufacturer0000api.fda.gov
Predo Saglik Urunleri Sanayi Ve Ticaret Anonim SirketiSEHITKAMIL Gaziantep, TurkeyContract manufacturer, Manufacturer0000api.fda.gov
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.Shenzhen Guangdong, ChinaManufacturer0000api.fda.gov
Shenzhen Mindray Bio-Medical Electronics Co.,LTDSHENZHEN Guangdong, ChinaExporter to the US, Specification developer0000api.fda.gov
Siemens Healthcare Diagnostics Inc.Tarrytown, NY, United StatesSpecification developer0000api.fda.gov
Siemens Healthcare Diagnostics Products GmbHMARBURG Hesse, GermanyManufacturer0000api.fda.gov
TechnocloneVienna Wien, AustriaContract manufacturer0000api.fda.gov
Technogenetics SPALodi, ItalyManufacturer0000api.fda.gov
Thermo Fisher Scientific OYVANTAA Uusimaa, FinlandManufacturer0000api.fda.gov
URIT Medical Electronic Co., Ltd.Guilin Guangxi, ChinaManufacturer0000api.fda.gov
Wavesense, Inc.Irvine, CA, United StatesManufacturer0000api.fda.gov
Weiman Products, LLCGurnee, IL, United StatesContract manufacturer, Manufacturer0000api.fda.gov

Updated November 2, 2026. 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.