Data / Medical devices / Colorimeter, Photometer, Spectrophotometer For Clinical Use
Colorimeter, Photometer, Spectrophotometer For Clinical Use (JJQ): 74 FDA-registered makers in 19 countries
74 establishments in 19 countries are registered with the FDA to make Colorimeter, Photometer, Spectrophotometer For Clinical Use (product code JJQ, Class 1, 21 CFR 862.2300). 8 of them have a 510(k) clearance or PMA approval on file and 4 have a recall event. The FDA has issued 258 510(k) clearances under this code, the latest on December 21, 2001, and lists 10 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- JJQ
- Device class
- 1
- Regulation
- 862.2300
- Medical specialty
- Clinical Chemistry
Makers by country
| Country | Makers |
|---|---|
| United States | 34 |
| China | 12 |
| Germany | 4 |
| United Kingdom | 3 |
| Switzerland | 3 |
| Taiwan | 2 |
| France | 2 |
| Malaysia | 2 |
| India | 2 |
| Finland | 1 |
| Japan | 1 |
| Egypt | 1 |
| South Korea | 1 |
| Spain | 1 |
| Estonia | 1 |
| Israel | 1 |
| Canada | 1 |
| Austria | 1 |
| Netherlands | 1 |
Makers of Colorimeter, Photometer, Spectrophotometer 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 |
|---|---|---|---|---|---|---|---|---|
| Chong Qing Teco Huayi Pharm. Co. | Shapingba Dist., Chongqing, China | Contract manufacturer, Manufacturer, Repackager or relabeler | 2 | March 1, 1990 | 0 | 0 | 0 | api.fda.gov |
| Teco Diagnostics | Anaheim, CA, United States | Manufacturer | 2 | March 1, 1990 | 0 | 0 | 0 | api.fda.gov |
| Beckman Coulter, Inc. | West Sacramento, CA, United States | Specification developer | 1 | March 17, 1980 | 0 | 1 | 0 | api.fda.gov |
| Diagnostic Automation/ Cortez Diagnostics Inc,. | Woodland Hills, CA, United States | Manufacturer | 1 | March 1, 1990 | 0 | 0 | 0 | api.fda.gov |
| Hologic, Inc. | San Diego, CA, United States | Manufacturer | 1 | January 23, 1991 | 0 | 0 | 0 | api.fda.gov |
| Siemens Healthcare Diagnostics Inc. | Newark, DE, United States | Manufacturer | 1 | January 11, 1991 | 0 | 0 | 0 | api.fda.gov |
| Siemens Healthcare Diagnostics Products Limited | LLANBERIS Wales, United Kingdom | Complaint file establishment, Specification developer | 1 | January 11, 1991 | 0 | 0 | 0 | api.fda.gov |
| Siemens Healthcare Diagnostics Products GmbH | MARBURG Hesse, Germany | Manufacturer | 1 | January 11, 1991 | 0 | 0 | 0 | api.fda.gov |
| Aidian OY | ESPOO Uusimaa, Finland | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Apollo Biotech Co., Ltd. | New Taipei City, Taiwan | Exporter to the US, 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 | |
| Astoria-Pacific, Inc. | Clackamas, OR, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Atom Medical Corporation | Sakura-ku, Saitama-shi, Japan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Awareness Technology, Inc. | Palm City, FL, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Advanced Instruments, LLC | Westbrook, ME, United States | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Agilent Technologies, Inc | Santa Clara, CA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Agilent Technologies, Inc. | Winooski, VT, United States | Manufacturer | 0 | 0 | 1 | 0 | api.fda.gov | |
| Ameditech, Inc. | San Diego, CA, United States | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Applied BioCode, Inc. | Santa Fe Springs, CA, United States | Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Baebies Inc. | Durham, NC, United States | Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov | |
| Beckman Coulter, Inc. | Miami, FL, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Becton, Dickinson & Co. | Sparks, MD, United States | Complaint file establishment, Specification developer | 0 | 0 | 1 | 0 | api.fda.gov | |
| Bio-Rad | MARNES-LA-COQUETTE Ile-de-France, France | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Biobase Biodustry(shandong)co., Ltd | Jinan Shandong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| BIOMERIEUX SA - Grenoble | Grenoble Cedex 01 Auvergne-Rhone-Alpes, France | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Buhlmann Laboratories AG | SCHONENBUCH/BASEL Basel-Landschaft, Switzerland | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Cerium Visual Technologies Ltd. | Tenterden, Kent, United Kingdom | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Chembio Diagnostic Systems, Inc. | Medford, NY, United States | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Codonics, Inc. | Middleburg Heights, OH, United States | Complaint file establishment, Manufacturer, Remanufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dentognostics GMBH | Solingen North Rhine-Westphalia, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Diasorin Inc. | Stillwater, MN, United States | Manufacturer, Repackager or relabeler, Specification developer | 0 | 0 | 1 | 0 | api.fda.gov | |
| Dirui Industrial Co., Ltd. | CHANGCHUN Jilin, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| DRG Instruments GMBH | MARBURG Hesse, Germany | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dynex Technologies, Inc. | Chantilly, VA, United States | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Derungs Licht AG | Gossau Sankt Gallen, Switzerland | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Elhoda Trade And Supplies | Badr industerial city Al Qahirah, Egypt | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Genrui Biotech Inc | Shenzhen Guangdong, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Good Doctors Co., Ltd. | Incheon Seoul, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Guangzhou Konmison Technology Co., Ltd. | Guangzhou Guangdong, China | 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 | |
| Hemagen Diagnostics, Inc. | Baltimore, MD, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| High Technology, Inc. | North Attleboro, MA, United States | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Immunocentrix Corporation | Canoga Park, CA, United States | Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov | |
| IMMY, Inc. | Norman, OK, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Infitek Co., Ltd. | Shanghai, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Iul SA | Barcelona, Spain | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Innokas Medical Estonia Ou | Tallinn Harjumaa, Estonia | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jabil Circuit Sdn. Bhd. | Bayan Lepas Pulau Pinang, Malaysia | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Labpeak Co.,ltd | Jinan Shandong, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Logic PD, Inc. | Eden Prairie, MN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Medtox Diagnostics, Inc. | Burlington, NC, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Medtox Diagnostics, Inc. | Burlington, NC, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Monobind, Inc. | Lake Forest, CA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Motion Dental Equipment Corporation | New Taipei City, Taiwan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Meridian Bioscience Israel Ltd. | Modiin Central, Israel | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Princeton Biomeditech Corp. | Monmouth Jct, NJ, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Plexus Manufacturing Sdn.Bhd. | Bayan Lepas Pulau Pinang, Malaysia | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Princeton BioMeditech Corp. | Plainsboro, NJ, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Princeton BioMeditech Corp. | Skillman, NJ, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Q-Line Biotech Limited | Lucknow Uttar Pradesh, India | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Qiagen, GMBH | HILDEN North Rhine-Westphalia, Germany | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Qualigen, Inc. | Carlsbad, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Scitek Global Co.,ltd | Jinan Shandong, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shanghai Kehua Laboratory System Co., Ltd. | Shanghai, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shijiazhuang Hipro Biotechnology Co.,ltd | Shijiazhuang Hebei, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Smile Line SA | St-Imier Bern, Switzerland | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Spectrochip Global Inc. | Burlington Ontario, Canada | Exporter to the US, Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Sterile Safequip & Chemicals Limited | Ahmedabad Gujarat, India | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Tecan Austria GMBH | GROEDIG Salzburg, Austria | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Technovent Limited | Bridgend, United Kingdom | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Unico (shanghai) Instrument Co., Ltd. | Shanghai, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Vigilant Biosciences Inc. | Lakeway, TX, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| VitalScientific B.V. | SPANKEREN Gelderland, Netherlands | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Zhejiang Orient Gene Biotech | Huzhou Zhejiang, China | Contract manufacturer, Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated December 21, 2001. 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.