Data / Medical devices / Ph Rate Measurement, Carbon-Dioxide
Ph Rate Measurement, Carbon-Dioxide (JFL): 11 FDA-registered makers in 4 countries
11 establishments in 4 countries are registered with the FDA to make Ph Rate Measurement, Carbon-Dioxide (product code JFL, Class 2, 21 CFR 862.1160). 4 of them have a 510(k) clearance or PMA approval on file and 1 has a recall event. The FDA has issued 28 510(k) clearances under this code, the latest on February 7, 2020, and lists 2 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- JFL
- Device class
- 2
- Regulation
- 862.1160
- Medical specialty
- Clinical Chemistry
Makers by country
| Country | Makers |
|---|---|
| United States | 6 |
| Canada | 3 |
| Ireland | 1 |
| Germany | 1 |
Makers of Ph Rate Measurement, Carbon-Dioxide
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 | February 7, 2020 | 0 | 0 | 0 | api.fda.gov |
| Abbott Point Of Care Inc. | Princeton, NJ, United States | Complaint file establishment, Manufacturer, Specification developer | 1 | February 7, 2020 | 0 | 0 | 0 | api.fda.gov |
| Carolina Liquid Chemistries | Brea, CA, United States | Manufacturer, Repackager or relabeler | 1 | December 27, 2004 | 0 | 0 | 0 | api.fda.gov |
| Nova Biomedical Corporation | Waltham, MA, United States | Contract manufacturer, Manufacturer, Remanufacturer | 1 | August 23, 1996 | 0 | 0 | 0 | api.fda.gov |
| Beckman Coulter, Inc. | Brea, CA, United States | Manufacturer, Specification developer | 0 | 0 | 1 | 0 | api.fda.gov | |
| Beckman Coulter, Inc. | Carlsbad, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Beckman Coulter Ireland Inc | O CALLAGHANS MILLS Clare, Ireland | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Epocal, Inc. | Ottawa Ontario, Canada | Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Epocal Inc | Ottawa Ontario, Canada | Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Philips Medizin Systeme Boeblingen GmbH | BOEBLINGEN Baden-Wurttemberg, Germany | Complaint file establishment, Specification developer | 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, 2020. 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.