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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.

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
JJQ
Device class
1
Regulation
862.2300
Medical specialty
Clinical Chemistry

Makers by country

CountryMakers
United States34
China12
Germany4
United Kingdom3
Switzerland3
Taiwan2
France2
Malaysia2
India2
Finland1
Japan1
Egypt1
South Korea1
Spain1
Estonia1
Israel1
Canada1
Austria1
Netherlands1

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.

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Chong Qing Teco Huayi Pharm. Co.Shapingba Dist., Chongqing, ChinaContract manufacturer, Manufacturer, Repackager or relabeler2March 1, 1990000api.fda.gov
Teco DiagnosticsAnaheim, CA, United StatesManufacturer2March 1, 1990000api.fda.gov
Beckman Coulter, Inc.West Sacramento, CA, United StatesSpecification developer1March 17, 1980010api.fda.gov
Diagnostic Automation/ Cortez Diagnostics Inc,.Woodland Hills, CA, United StatesManufacturer1March 1, 1990000api.fda.gov
Hologic, Inc.San Diego, CA, United StatesManufacturer1January 23, 1991000api.fda.gov
Siemens Healthcare Diagnostics Inc.Newark, DE, United StatesManufacturer1January 11, 1991000api.fda.gov
Siemens Healthcare Diagnostics Products LimitedLLANBERIS Wales, United KingdomComplaint file establishment, Specification developer1January 11, 1991000api.fda.gov
Siemens Healthcare Diagnostics Products GmbHMARBURG Hesse, GermanyManufacturer1January 11, 1991000api.fda.gov
Aidian OYESPOO Uusimaa, FinlandManufacturer0000api.fda.gov
Apollo Biotech Co., Ltd.New Taipei City, TaiwanExporter to the US, Specification developer0000api.fda.gov
Associates Of Cape Cod, Inc.E Falmouth, MA, United StatesManufacturer0000api.fda.gov
Astoria-Pacific, Inc.Clackamas, OR, United StatesManufacturer0000api.fda.gov
Atom Medical CorporationSakura-ku, Saitama-shi, JapanManufacturer0000api.fda.gov
Awareness Technology, Inc.Palm City, FL, United StatesManufacturer0000api.fda.gov
Advanced Instruments, LLCWestbrook, ME, United StatesContract manufacturer, Manufacturer0000api.fda.gov
Agilent Technologies, IncSanta Clara, CA, United StatesSpecification developer0000api.fda.gov
Agilent Technologies, Inc.Winooski, VT, United StatesManufacturer0010api.fda.gov
Ameditech, Inc.San Diego, CA, United StatesComplaint file establishment, Manufacturer0000api.fda.gov
Applied BioCode, Inc.Santa Fe Springs, CA, United StatesManufacturer, Specification developer0000api.fda.gov
Baebies Inc.Durham, NC, United StatesManufacturer for export0000api.fda.gov
Beckman Coulter, Inc.Miami, FL, United StatesContract manufacturer0000api.fda.gov
Becton, Dickinson & Co.Sparks, MD, United StatesComplaint file establishment, Specification developer0010api.fda.gov
Bio-RadMARNES-LA-COQUETTE Ile-de-France, FranceSpecification developer0000api.fda.gov
Biobase Biodustry(shandong)co., LtdJinan Shandong, ChinaManufacturer0000api.fda.gov
BIOMERIEUX SA - GrenobleGrenoble Cedex 01 Auvergne-Rhone-Alpes, FranceManufacturer0000api.fda.gov
Buhlmann Laboratories AGSCHONENBUCH/BASEL Basel-Landschaft, SwitzerlandManufacturer0000api.fda.gov
Cerium Visual Technologies Ltd.Tenterden, Kent, United KingdomManufacturer0000api.fda.gov
Chembio Diagnostic Systems, Inc.Medford, NY, United StatesComplaint file establishment, Manufacturer0000api.fda.gov
Codonics, Inc.Middleburg Heights, OH, United StatesComplaint file establishment, Manufacturer, Remanufacturer0000api.fda.gov
Dentognostics GMBHSolingen North Rhine-Westphalia, GermanyManufacturer0000api.fda.gov
Diasorin Inc.Stillwater, MN, United StatesManufacturer, Repackager or relabeler, Specification developer0010api.fda.gov
Dirui Industrial Co., Ltd.CHANGCHUN Jilin, ChinaManufacturer0000api.fda.gov
DRG Instruments GMBHMARBURG Hesse, GermanyComplaint file establishment, Manufacturer0000api.fda.gov
Dynex Technologies, Inc.Chantilly, VA, United StatesComplaint file establishment, Manufacturer0000api.fda.gov
Derungs Licht AGGossau Sankt Gallen, SwitzerlandManufacturer0000api.fda.gov
Elhoda Trade And SuppliesBadr industerial city Al Qahirah, EgyptManufacturer0000api.fda.gov
Genrui Biotech IncShenzhen Guangdong, ChinaExporter to the US, Manufacturer0000api.fda.gov
Good Doctors Co., Ltd.Incheon Seoul, South KoreaManufacturer0000api.fda.gov
Guangzhou Konmison Technology Co., Ltd.Guangzhou Guangdong, ChinaManufacturer0000api.fda.gov
Healgen Scientific LLCHouston, TX, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Hemagen Diagnostics, Inc.Baltimore, MD, United StatesManufacturer0000api.fda.gov
High Technology, Inc.North Attleboro, MA, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
Immunocentrix CorporationCanoga Park, CA, United StatesManufacturer for export0000api.fda.gov
IMMY, Inc.Norman, OK, United StatesManufacturer0000api.fda.gov
Infitek Co., Ltd.Shanghai, ChinaManufacturer0000api.fda.gov
Iul SABarcelona, SpainContract manufacturer, Manufacturer0000api.fda.gov
Innokas Medical Estonia OuTallinn Harjumaa, EstoniaContract manufacturer0000api.fda.gov
Jabil Circuit Sdn. Bhd.Bayan Lepas Pulau Pinang, MalaysiaContract manufacturer0000api.fda.gov
Labpeak Co.,ltdJinan Shandong, ChinaExporter to the US, Manufacturer0000api.fda.gov
Logic PD, Inc.Eden Prairie, MN, United StatesContract manufacturer0000api.fda.gov
Medtox Diagnostics, Inc.Burlington, NC, United StatesManufacturer0000api.fda.gov
Medtox Diagnostics, Inc.Burlington, NC, United StatesManufacturer0000api.fda.gov
Monobind, Inc.Lake Forest, CA, United StatesSpecification developer0000api.fda.gov
Motion Dental Equipment CorporationNew Taipei City, TaiwanManufacturer0000api.fda.gov
Meridian Bioscience Israel Ltd.Modiin Central, IsraelManufacturer0000api.fda.gov
Princeton Biomeditech Corp.Monmouth Jct, NJ, United StatesManufacturer0000api.fda.gov
Plexus Manufacturing Sdn.Bhd.Bayan Lepas Pulau Pinang, MalaysiaContract manufacturer0000api.fda.gov
Princeton BioMeditech Corp.Plainsboro, NJ, United StatesManufacturer0000api.fda.gov
Princeton BioMeditech Corp.Skillman, NJ, United StatesManufacturer0000api.fda.gov
Q-Line Biotech LimitedLucknow Uttar Pradesh, IndiaManufacturer0000api.fda.gov
Qiagen, GMBHHILDEN North Rhine-Westphalia, GermanySpecification developer0000api.fda.gov
Qualigen, Inc.Carlsbad, CA, United StatesManufacturer0000api.fda.gov
Scitek Global Co.,ltdJinan Shandong, ChinaExporter to the US, Manufacturer0000api.fda.gov
Shanghai Kehua Laboratory System Co., Ltd.Shanghai, ChinaManufacturer0000api.fda.gov
Shijiazhuang Hipro Biotechnology Co.,ltdShijiazhuang Hebei, ChinaManufacturer0000api.fda.gov
Smile Line SASt-Imier Bern, SwitzerlandManufacturer0000api.fda.gov
Spectrochip Global Inc.Burlington Ontario, CanadaExporter to the US, Repackager or relabeler, Specification developer0000api.fda.gov
Sterile Safequip & Chemicals LimitedAhmedabad Gujarat, IndiaManufacturer0000api.fda.gov
Tecan Austria GMBHGROEDIG Salzburg, AustriaContract manufacturer, Manufacturer0000api.fda.gov
Technovent LimitedBridgend, United KingdomManufacturer0000api.fda.gov
Unico (shanghai) Instrument Co., Ltd.Shanghai, ChinaManufacturer0000api.fda.gov
Vigilant Biosciences Inc.Lakeway, TX, United StatesManufacturer0000api.fda.gov
VitalScientific B.V.SPANKEREN Gelderland, NetherlandsManufacturer0000api.fda.gov
Zhejiang Orient Gene BiotechHuzhou Zhejiang, ChinaContract manufacturer, Exporter to the US, Manufacturer0000api.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.