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
| Country | Makers |
|---|---|
| United States | 39 |
| Germany | 10 |
| France | 8 |
| Japan | 7 |
| China | 6 |
| Taiwan | 4 |
| Switzerland | 3 |
| Italy | 3 |
| Hong Kong | 3 |
| Canada | 2 |
| India | 2 |
| Austria | 2 |
| United Kingdom | 1 |
| Poland | 1 |
| Netherlands | 1 |
| Mexico | 1 |
| Australia | 1 |
| Egypt | 1 |
| Spain | 1 |
| Ireland | 1 |
| Finland | 1 |
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.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Abbott Diabetes Care Inc. | Alameda, CA, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Abbott Diabetes Care Limited | WITNEY OXON Oxfordshire, United Kingdom | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Abbott Laboratories | Irving, TX, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Acon Biotech (hangzhou) Co., Ltd. | HANGZHOU Zhejiang, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Acon Laboratories, Inc. | San Diego, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| AESKU.DIAGNOSTICS GmbH&Co.KG | WENDELSHEIM Rhineland-Palatinate, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ascensia Diabetes Care Holdings AG | Basel Basel-Stadt, Switzerland | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Associates Of Cape Cod, Inc. | E Falmouth, MA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Abbott Automation Solutions GmbH | Hamburg, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Abbott S.r.l. | Milan Lombardy, Italy | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Aclarion, Inc. | Broomfield, CO, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ascensia Diabetes Care Poland Sp. z o.o. | Warszawa Mazowieckie, Poland | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ascensia Diabetes Care US Inc. | Parsippany, NJ, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ascensia Diabetes Care US Inc. | Valhalla, NY, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| BD Kiestra B.V. | Drachten Fryslan, Netherlands | Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Beckman Coulter, Inc. | Miami, FL, United States | Manufacturer | 0 | 0 | 1 | 0 | api.fda.gov | |
| Becton, Dickinson & Co. | Sparks, MD, United States | Complaint file establishment, Manufacturer, Specification developer | 0 | 0 | 7 | 0 | api.fda.gov | |
| Bio-Rad | MARNES-LA-COQUETTE Ile-de-France, France | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Biomerieux SA | LA BALME LES GROTTES Isere, France | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Biomerieux, Inc. | Hazelwood, MO, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Bionostics, Inc. | Devens, MA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Byg Informatique | L Union Haute-Garonne, France | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Beckman Coulter Biomedical GmbH | Baierbrunn Bavaria, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Beckman Coulter Biomedical GmbH | Munchen Bavaria, Germany | Specification developer | 0 | 0 | 1 | 0 | api.fda.gov | |
| Compass Bioinformatics Inc. | Hsinchu City Hsinchu(City), Taiwan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| CliniSys, Inc | Tucson, AZ, United States | Manufacturer | 0 | 0 | 44 | 0 | api.fda.gov | |
| Copan WASP | Brescia Lombardy, Italy | Manufacturer | 0 | 0 | 1 | 0 | api.fda.gov | |
| Data Innovations, LLC | Colchester, VT, United States | Manufacturer | 0 | 0 | 6 | 0 | api.fda.gov | |
| De Novo Software | Pasadena, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Diagnostica Stago, Inc. | Parsippany, NJ, United States | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dongguan Bao Kang Dian Zi Ke Ji Limited | Dongguan City Guangdong, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Diagnostica Stago - Gennevilliers | Gennevilliers Hauts-de-Seine, France | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Echosens | Paris, France | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ekf Diagnostic GMBH | BARLEBEN/MADGEBURG Saxony-Anhalt, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Epocal, Inc. | Ottawa Ontario, Canada | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Foshan Zike Technology Co., Ltd. | Foshan Guangdong, China | 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 | |
| GL Diabetes Corporation | San Diego, CA, United States | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Gorgeous Beauty Equipment Manufacture Limited | Hong Kong, Hong Kong | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hebei Mita Technology Limited | Hong Kong, Hong Kong | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| HITACHI HIGH-TECH CORP., Musashimurayama Center | Musashimurayama Tokyo, Japan | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hitachi High-Tech Corp., Naka Division | Hitachinaka-shi Ibaraki, Japan | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| HITACHI HIGH-TECH CORP., Ome Works | Ome-Shi Tokyo, Japan | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| HMD Biomedical, Inc. | Hsinchu County Hsinchu(County), Taiwan | Contract manufacturer, Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Horiba Abx SAS | MONTPELLIER Herault, France | Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hitachi High-Tech Corp., Omuta Center | Omuta-shi Fukuoka, Japan | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Indigo Bioautomation, Inc. | Carmel, IN, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Inpeco S.P.A. | Val della Torre Torino, Italy | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Inpeco SA | Novazzano Ticino, Switzerland | Specification developer | 0 | 0 | 4 | 0 | api.fda.gov | |
| Instrumentation Laboratory Co. | Orangeburg, NY, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Kikuyo Factory | Kumamoto, Japan | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Lattice, Inc. | Wheaton, IL, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Leica Biosystems Melbourne Pty Ltd | MELBOURNE Victoria, Australia | Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Life Data Lab, LLC | New York, NY, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Leavitt Medical, Inc. | Lehi, UT, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Mark Enterprises | Nashik Maharashtra, India | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Marken Healthtech Limited | NASHIK Maharashtra, India | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Musclesound, Inc. | Englewood, CO, United States | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Medical Information Technology, Inc. | Canton, MA, United States | Manufacturer | 0 | 0 | 3 | 0 | api.fda.gov | |
| Millstone Medical Outsourcing LLC | Olive Branch, MS, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| National Technology For Software | Cairo Al Qahirah, Egypt | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Nidek Co., Ltd. | Gamagori, Aichi, Japan | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Nidek Co., Ltd. Hamacho Plant | Gamagori, Aichi, Japan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Nidek Incorporated | The Colony, TX, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Normand-Info S.A.S.U. | ARRAS Pas-de-Calais, France | Manufacturer | 0 | 0 | 4 | 0 | api.fda.gov | |
| Ok Biotech Co., Ltd. | HSINCHU CITY Hsinchu(County), Taiwan | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Oman Medical Beauty Manufacture Limited | Hong Kong, Hong Kong | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Omnitech Labs Inc. | St-Jean-sur-Richelieu Quebec, Canada | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Philips Medizin Systeme Boeblingen GmbH | BOEBLINGEN Baden-Wurttemberg, Germany | Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Roche Diabetes Care, Inc. | Indianapolis, IN, United States | Manufacturer | 0 | 0 | 2 | 0 | api.fda.gov | |
| Roche Diagnostics GMBH | MANNHEIM Baden-Wurttemberg, Germany | Exporter to the US, Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Roche Diagnostics International Ltd. | ROTKREUZ Zug, Switzerland | Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Roche Molecular Systems, Inc. | Branchburg, NJ, United States | 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 | |
| RXMX, Inc. | New York, NY, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Roche Diabetes Care GmbH | Mannheim Baden-Wurttemberg, Germany | Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Roche Diagnostics Automation Solutions GmbH | Ludwigsburg Baden-Wurttemberg, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Roche Diagnostics S.L. | Sant Cugat del Valles Barcelona, Spain | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Roche Diagnostics Santa Clara | Santa Clara, CA, United States | Manufacturer, Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov | |
| SCC Soft Computer | Clearwater, FL, United States | Complaint file establishment, Manufacturer | 0 | 0 | 19 | 0 | api.fda.gov | |
| Shanghai Bestcovered Limited | Shanghai, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Siemens Healthcare Diagnostics Inc. | Newark, DE, United States | Manufacturer | 0 | 0 | 9 | 0 | api.fda.gov | |
| Siemens Healthcare Diagnostics Inc | East Walpole, MA, United States | Complaint file establishment, Specification developer | 0 | 0 | 1 | 0 | api.fda.gov | |
| Siemens Healthcare Diagnostics Inc. | Tarrytown, NY, United States | Complaint file establishment, Specification developer | 0 | 0 | 1 | 0 | api.fda.gov | |
| Siemens Healthcare Diagnostics Manufacturing Ltd. | SWORDS Dublin(County), Ireland | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Siemens Healthcare GmbH | Berlin, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Stryker Instruments | Portage, MI, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Sysmex America, Inc. | Lincolnshire, IL, United States | Complaint file establishment, Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Taidoc Technology Corporation | New Taipei City, Taiwan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Tecan Austria GMBH | GROEDIG Salzburg, Austria | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Technidata | MONTBONNOT ST. MARTIN Isere, France | Manufacturer | 0 | 0 | 4 | 0 | api.fda.gov | |
| Technoclone | Vienna Wien, Austria | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Telcor Inc | Lincoln, NE, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Tianjin Empecs Medical Device Co., Ltd. | Tianjin, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Telcare, LLC | Linwood, PA, United States | Complaint file establishment, Manufacturer, Specification developer | 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 | |
| Wallac OY | TURKU Varsinais-Suomi, Finland | Complaint file establishment, Manufacturer | 0 | 0 | 3 | 0 | api.fda.gov | |
| Zhejiang Gene Science Co., Ltd | shaoxing Zhejiang, China | Manufacturer | 0 | 0 | 0 | 0 | api.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.