Data / Medical devices / Electrode, Ion Based, Enzymatic, Creatinine / United States
FDA-registered makers of Electrode, Ion Based, Enzymatic, Creatinine in the United States: 5 establishments
5 establishments in the United States are registered with the FDA to make Electrode, Ion Based, Enzymatic, Creatinine (product code CGL). 3 have a 510(k) clearance or PMA approval on file and 2 have a recall event. FDA data exported November 2, 2026.
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- Device
- Electrode, Ion Based, Enzymatic, Creatinine
- Product code
- CGL
- Country
- United States
Makers of Electrode, Ion Based, Enzymatic, Creatinine in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| 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 |
| Abbott Point Of Care Inc. | Princeton, NJ, United States | Complaint file establishment, Manufacturer, Specification developer | 0 | 0 | 1 | 0 | api.fda.gov | |
| Nova Biomedical Corporation | Billerica, MA, United States | Manufacturer, Manufacturer for export, Remanufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated November 2, 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.