Data / Medical devices / Colorimetry, Cholinesterase
Colorimetry, Cholinesterase (DIH): 18 FDA-registered makers in 8 countries
18 establishments in 8 countries are registered with the FDA to make Colorimetry, Cholinesterase (product code DIH, Class 1, 21 CFR 862.3240). 10 of them have a 510(k) clearance or PMA approval on file and 1 has a recall event. The FDA has issued 26 510(k) clearances under this code, the latest on February 7, 2011, and lists 2 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- DIH
- Device class
- 1
- Regulation
- 862.3240
- Medical specialty
- Clinical Toxicology
Makers by country
| Country | Makers |
|---|---|
| United States | 10 |
| Germany | 2 |
| Ireland | 1 |
| United Kingdom | 1 |
| Argentina | 1 |
| China | 1 |
| Egypt | 1 |
| Switzerland | 1 |
Makers of Colorimetry, Cholinesterase
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 |
|---|---|---|---|---|---|---|---|---|
| Beckman Coulter Ireland Inc | O CALLAGHANS MILLS Clare, Ireland | Manufacturer | 2 | February 7, 2011 | 0 | 0 | 0 | api.fda.gov |
| Beckman Coulter, Inc. | Brea, CA, United States | Specification developer | 1 | February 7, 2011 | 0 | 0 | 0 | api.fda.gov |
| Cliniqa Corporation | San Marcos, CA, United States | Manufacturer | 1 | June 27, 1986 | 0 | 0 | 0 | api.fda.gov |
| Eqm Research, Inc. | Cheviot, OH, United States | Manufacturer | 1 | November 26, 1996 | 0 | 0 | 0 | api.fda.gov |
| Fisher Diagnostics | Middletown, VA, United States | Manufacturer | 1 | October 17, 1979 | 0 | 0 | 0 | api.fda.gov |
| Randox Laboratories Limited | CRUMLIN, COUNTY ANTRIM Antrim and Newtownabbey, United Kingdom | Contract manufacturer, Manufacturer | 1 | January 18, 2002 | 0 | 0 | 0 | api.fda.gov |
| Roche Diagnostics GMBH | MANNHEIM Baden-Wurttemberg, Germany | Exporter to the US, Manufacturer, Repackager or relabeler, Specification developer | 1 | July 3, 2006 | 0 | 0 | 0 | api.fda.gov |
| Siemens Healthcare Diagnostics Inc. | Tarrytown, NY, United States | Complaint file establishment, Specification developer | 1 | January 18, 2002 | 0 | 0 | 0 | api.fda.gov |
| Teco Diagnostics | Anaheim, CA, United States | Manufacturer | 1 | December 18, 1991 | 0 | 0 | 0 | api.fda.gov |
| Wiener Laboratorios S.A.I.C. | ROSARIO Santa Fe, Argentina | Manufacturer | 1 | February 12, 2003 | 0 | 0 | 0 | api.fda.gov |
| Beckman Coulter, Inc. | Carlsbad, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Biobase Biodustry(shandong)co., Ltd | Jinan Shandong, China | 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 | |
| Ortho-Clinical Diagnostics, Inc. | Rochester, NY, United States | Complaint file establishment, Specification developer | 0 | 0 | 2 | 0 | api.fda.gov | |
| Ortho-Clinical Diagnostics, Inc. | Rochester, NY, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Roche Diagnostics GMBH | PENZBERG Bavaria, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Roche Diagnostics International Ltd. | ROTKREUZ Zug, Switzerland | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Siemens Healthcare Diagnostics Inc. | Newark, DE, United States | Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated February 7, 2011. 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.