Data / Medical devices / Electrode, Ion Based, Enzymatic, Creatinine
Electrode, Ion Based, Enzymatic, Creatinine (CGL): 11 FDA-registered makers in 4 countries
11 establishments in 4 countries are registered with the FDA to make Electrode, Ion Based, Enzymatic, Creatinine (product code CGL, Class 2, 21 CFR 862.1225). 6 of them have a 510(k) clearance or PMA approval on file and 2 have a recall event. The FDA has issued 8 510(k) clearances under this code, the latest on June 26, 2026, and lists 7 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- CGL
- Device class
- 2
- Regulation
- 862.1225
- Medical specialty
- Clinical Chemistry
Makers by country
| Country | Makers |
|---|---|
| United States | 5 |
| Canada | 3 |
| Poland | 2 |
| Denmark | 1 |
Makers of Electrode, Ion Based, Enzymatic, Creatinine
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 Point Of Care Canada Limited | Ottawa Ontario, Canada | Manufacturer | 1 | October 20, 1997 | 0 | 0 | 0 | api.fda.gov |
| Epocal, Inc. | Ottawa Ontario, Canada | Manufacturer, Specification developer | 1 | October 5, 2012 | 0 | 0 | 0 | api.fda.gov |
| Nova Biomedical Corporation | Waltham, MA, United States | Contract manufacturer, Manufacturer, Manufacturer for export, Remanufacturer | 1 | May 7, 2007 | 0 | 2 | 0 | api.fda.gov |
| Nova Biomedical Corporation Diabetes Products | Billerica, MA, United States | Complaint file establishment, Contract manufacturer, Manufacturer, Remanufacturer | 1 | May 7, 2007 | 0 | 0 | 0 | api.fda.gov |
| Nova Biomedical Corporation | Billerica, MA, United States | Complaint file establishment, Manufacturer, Remanufacturer | 1 | May 7, 2007 | 0 | 0 | 0 | api.fda.gov |
| Radiometer Medical Aps | BROENSHOEJ Hovedstaden, Denmark | Complaint file establishment, Manufacturer | 1 | October 16, 2006 | 0 | 0 | 0 | api.fda.gov |
| Abbott Point Of Care Inc. | Princeton, NJ, United States | Complaint file establishment, Manufacturer, Specification developer | 0 | 0 | 1 | 0 | api.fda.gov | |
| Epocal Inc | Ottawa Ontario, Canada | Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Nova Biomedical Corporation | Billerica, MA, United States | Manufacturer, Manufacturer for export, Remanufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Radiometer Solutions Sp. z o.o. | Stargard Zachodniopomorskie, Poland | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Radiometer Sp. z o.o | Stargard Zachodniopomorskie, Poland | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated June 26, 2026. 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.