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Data / Medical devices / Calculator/Data Processing Module, For Clinical Use

Calculator/Data Processing Module, For Clinical Use (JQP): 98 FDA-registered makers in 21 countries

98 establishments in 21 countries are registered with the FDA to make Calculator/Data Processing Module, For Clinical Use (product code JQP, Class 1, 21 CFR 862.2100). 0 of them have a 510(k) clearance or PMA approval on file and 16 have a recall event. The FDA has issued 78 510(k) clearances under this code, the latest on February 27, 2012, and lists 188 recall events (0 Class I). FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Product code
JQP
Device class
1
Regulation
862.2100
Medical specialty
Clinical Chemistry

Makers by country

CountryMakers
United States39
Germany10
France8
Japan7
China6
Taiwan4
Switzerland3
Italy3
Hong Kong3
Canada2
India2
Austria2
United Kingdom1
Poland1
Netherlands1
Mexico1
Australia1
Egypt1
Spain1
Ireland1
Finland1

Makers of Calculator/Data Processing Module, For Clinical Use

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 Diabetes Care Inc.Alameda, CA, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Abbott Diabetes Care LimitedWITNEY OXON Oxfordshire, United KingdomManufacturer0000api.fda.gov
Abbott LaboratoriesIrving, TX, United StatesSpecification developer0000api.fda.gov
Acon Biotech (hangzhou) Co., Ltd.HANGZHOU Zhejiang, ChinaContract manufacturer0000api.fda.gov
Acon Laboratories, Inc.San Diego, CA, United StatesManufacturer0000api.fda.gov
AESKU.DIAGNOSTICS GmbH&Co.KGWENDELSHEIM Rhineland-Palatinate, GermanyManufacturer0000api.fda.gov
Ascensia Diabetes Care Holdings AGBasel Basel-Stadt, SwitzerlandSpecification developer0000api.fda.gov
Associates Of Cape Cod, Inc.E Falmouth, MA, United StatesManufacturer0000api.fda.gov
Abbott Automation Solutions GmbHHamburg, GermanyManufacturer0000api.fda.gov
Abbott S.r.l.Milan Lombardy, ItalyManufacturer0000api.fda.gov
Aclarion, Inc.Broomfield, CO, United StatesManufacturer0000api.fda.gov
Ascensia Diabetes Care Poland Sp. z o.o.Warszawa Mazowieckie, PolandSpecification developer0000api.fda.gov
Ascensia Diabetes Care US Inc.Parsippany, NJ, United StatesSpecification developer0000api.fda.gov
Ascensia Diabetes Care US Inc.Valhalla, NY, United StatesComplaint file establishment, Specification developer0000api.fda.gov
BD Kiestra B.V.Drachten Fryslan, NetherlandsManufacturer, Specification developer0000api.fda.gov
Beckman Coulter, Inc.Miami, FL, United StatesManufacturer0010api.fda.gov
Becton, Dickinson & Co.Sparks, MD, United StatesComplaint file establishment, Manufacturer, Specification developer0070api.fda.gov
Bio-RadMARNES-LA-COQUETTE Ile-de-France, FranceSpecification developer0000api.fda.gov
Biomerieux SALA BALME LES GROTTES Isere, FranceManufacturer0000api.fda.gov
Biomerieux, Inc.Hazelwood, MO, United StatesManufacturer0000api.fda.gov
Bionostics, Inc.Devens, MA, United StatesContract manufacturer0000api.fda.gov
Byg InformatiqueL Union Haute-Garonne, FranceManufacturer0000api.fda.gov
Beckman Coulter Biomedical GmbHBaierbrunn Bavaria, GermanyContract manufacturer0000api.fda.gov
Beckman Coulter Biomedical GmbHMunchen Bavaria, GermanySpecification developer0010api.fda.gov
Compass Bioinformatics Inc.Hsinchu City Hsinchu(City), TaiwanManufacturer0000api.fda.gov
CliniSys, IncTucson, AZ, United StatesManufacturer00440api.fda.gov
Copan WASPBrescia Lombardy, ItalyManufacturer0010api.fda.gov
Data Innovations, LLCColchester, VT, United StatesManufacturer0060api.fda.gov
De Novo SoftwarePasadena, CA, United StatesManufacturer0000api.fda.gov
Diagnostica Stago, Inc.Parsippany, NJ, United StatesComplaint file establishment, Manufacturer0000api.fda.gov
Dongguan Bao Kang Dian Zi Ke Ji LimitedDongguan City Guangdong, ChinaContract manufacturer0000api.fda.gov
Diagnostica Stago - GennevilliersGennevilliers Hauts-de-Seine, FranceExporter to the US, Manufacturer0000api.fda.gov
EchosensParis, FranceManufacturer0000api.fda.gov
Ekf Diagnostic GMBHBARLEBEN/MADGEBURG Saxony-Anhalt, GermanyManufacturer0000api.fda.gov
Epocal, Inc.Ottawa Ontario, CanadaManufacturer0000api.fda.gov
Foshan Zike Technology Co., Ltd.Foshan Guangdong, ChinaManufacturer0000api.fda.gov
Flextronics Manufacturing Aguascalientes, S.A de C.VAguascalientes, MexicoContract manufacturer0000api.fda.gov
GL Diabetes CorporationSan Diego, CA, United StatesContract manufacturer, Manufacturer0000api.fda.gov
Gorgeous Beauty Equipment Manufacture LimitedHong Kong, Hong KongManufacturer0000api.fda.gov
Hebei Mita Technology LimitedHong Kong, Hong KongManufacturer0000api.fda.gov
HITACHI HIGH-TECH CORP., Musashimurayama CenterMusashimurayama Tokyo, JapanContract manufacturer0000api.fda.gov
Hitachi High-Tech Corp., Naka DivisionHitachinaka-shi Ibaraki, JapanContract manufacturer0000api.fda.gov
HITACHI HIGH-TECH CORP., Ome WorksOme-Shi Tokyo, JapanContract manufacturer0000api.fda.gov
HMD Biomedical, Inc.Hsinchu County Hsinchu(County), TaiwanContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov
Horiba Abx SASMONTPELLIER Herault, FranceManufacturer, Specification developer0000api.fda.gov
Hitachi High-Tech Corp., Omuta CenterOmuta-shi Fukuoka, JapanContract manufacturer0000api.fda.gov
Indigo Bioautomation, Inc.Carmel, IN, United StatesManufacturer0000api.fda.gov
Inpeco S.P.A.Val della Torre Torino, ItalyContract manufacturer0000api.fda.gov
Inpeco SANovazzano Ticino, SwitzerlandSpecification developer0040api.fda.gov
Instrumentation Laboratory Co.Orangeburg, NY, United StatesManufacturer0000api.fda.gov
Kikuyo FactoryKumamoto, JapanContract manufacturer, Manufacturer0000api.fda.gov
Lattice, Inc.Wheaton, IL, United StatesManufacturer0000api.fda.gov
Leica Biosystems Melbourne Pty LtdMELBOURNE Victoria, AustraliaManufacturer, Specification developer0000api.fda.gov
Life Data Lab, LLCNew York, NY, United StatesManufacturer0000api.fda.gov
Leavitt Medical, Inc.Lehi, UT, United StatesManufacturer0000api.fda.gov
Mark EnterprisesNashik Maharashtra, IndiaManufacturer0000api.fda.gov
Marken Healthtech LimitedNASHIK Maharashtra, IndiaManufacturer0000api.fda.gov
Musclesound, Inc.Englewood, CO, United StatesComplaint file establishment, Manufacturer0000api.fda.gov
Medical Information Technology, Inc.Canton, MA, United StatesManufacturer0030api.fda.gov
Millstone Medical Outsourcing LLCOlive Branch, MS, United StatesContract manufacturer0000api.fda.gov
National Technology For SoftwareCairo Al Qahirah, EgyptManufacturer0000api.fda.gov
Nidek Co., Ltd.Gamagori, Aichi, JapanSpecification developer0000api.fda.gov
Nidek Co., Ltd. Hamacho PlantGamagori, Aichi, JapanManufacturer0000api.fda.gov
Nidek IncorporatedThe Colony, TX, United StatesManufacturer0000api.fda.gov
Normand-Info S.A.S.U.ARRAS Pas-de-Calais, FranceManufacturer0040api.fda.gov
Ok Biotech Co., Ltd.HSINCHU CITY Hsinchu(County), TaiwanContract manufacturer0000api.fda.gov
Oman Medical Beauty Manufacture LimitedHong Kong, Hong KongManufacturer0000api.fda.gov
Omnitech Labs Inc.St-Jean-sur-Richelieu Quebec, CanadaComplaint file establishment, Manufacturer0000api.fda.gov
Philips Medizin Systeme Boeblingen GmbHBOEBLINGEN Baden-Wurttemberg, GermanyComplaint file establishment, Manufacturer, Repackager or relabeler, Specification developer0000api.fda.gov
Roche Diabetes Care, Inc.Indianapolis, IN, United StatesManufacturer0020api.fda.gov
Roche Diagnostics GMBHMANNHEIM Baden-Wurttemberg, GermanyExporter to the US, Manufacturer, Specification developer0000api.fda.gov
Roche Diagnostics International Ltd.ROTKREUZ Zug, SwitzerlandManufacturer, Specification developer0000api.fda.gov
Roche Molecular Systems, Inc.Branchburg, NJ, United StatesManufacturer0000api.fda.gov
RR Donnelley-Supply Chain SolutionsPlover, WI, United StatesContract manufacturer, Repackager or relabeler0000api.fda.gov
RXMX, Inc.New York, NY, United StatesManufacturer0000api.fda.gov
Roche Diabetes Care GmbHMannheim Baden-Wurttemberg, GermanyManufacturer, Specification developer0000api.fda.gov
Roche Diagnostics Automation Solutions GmbHLudwigsburg Baden-Wurttemberg, GermanyManufacturer0000api.fda.gov
Roche Diagnostics S.L.Sant Cugat del Valles Barcelona, SpainSpecification developer0000api.fda.gov
Roche Diagnostics Santa ClaraSanta Clara, CA, United StatesManufacturer, Manufacturer for export0000api.fda.gov
SCC Soft ComputerClearwater, FL, United StatesComplaint file establishment, Manufacturer00190api.fda.gov
Shanghai Bestcovered LimitedShanghai, ChinaManufacturer0000api.fda.gov
Siemens Healthcare Diagnostics Inc.Newark, DE, United StatesManufacturer0090api.fda.gov
Siemens Healthcare Diagnostics IncEast Walpole, MA, United StatesComplaint file establishment, Specification developer0010api.fda.gov
Siemens Healthcare Diagnostics Inc.Tarrytown, NY, United StatesComplaint file establishment, Specification developer0010api.fda.gov
Siemens Healthcare Diagnostics Manufacturing Ltd.SWORDS Dublin(County), IrelandManufacturer0000api.fda.gov
Siemens Healthcare GmbHBerlin, GermanyManufacturer0000api.fda.gov
Stryker InstrumentsPortage, MI, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Sysmex America, Inc.Lincolnshire, IL, United StatesComplaint file establishment, Manufacturer, Specification developer0000api.fda.gov
Taidoc Technology CorporationNew Taipei City, TaiwanManufacturer0000api.fda.gov
Tecan Austria GMBHGROEDIG Salzburg, AustriaContract manufacturer, Manufacturer0000api.fda.gov
TechnidataMONTBONNOT ST. MARTIN Isere, FranceManufacturer0040api.fda.gov
TechnocloneVienna Wien, AustriaContract manufacturer0000api.fda.gov
Telcor IncLincoln, NE, United StatesManufacturer0000api.fda.gov
Tianjin Empecs Medical Device Co., Ltd.Tianjin, ChinaManufacturer0000api.fda.gov
Telcare, LLCLinwood, PA, United StatesComplaint file establishment, Manufacturer, Specification developer0000api.fda.gov
Trividia Health, Inc.Fort Lauderdale, FL, United StatesComplaint file establishment, Manufacturer0000api.fda.gov
Wallac OYTURKU Varsinais-Suomi, FinlandComplaint file establishment, Manufacturer0030api.fda.gov
Zhejiang Gene Science Co., Ltdshaoxing Zhejiang, ChinaManufacturer0000api.fda.gov

Updated February 27, 2012. 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.