Data / Medical devices / Device, Hematocrit Measuring
Device, Hematocrit Measuring (JPI): 11 FDA-registered makers in 4 countries
11 establishments in 4 countries are registered with the FDA to make Device, Hematocrit Measuring (product code JPI, Class 2, 21 CFR 864.6400). 2 of them have a 510(k) clearance or PMA approval on file and 1 has a recall event. The FDA has issued 15 510(k) clearances under this code, the latest on February 28, 2020, and lists 2 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- JPI
- Device class
- 2
- Regulation
- 864.6400
- Medical specialty
- Hematology
Makers by country
| Country | Makers |
|---|---|
| United States | 6 |
| Canada | 3 |
| Germany | 1 |
| Poland | 1 |
Makers of Device, Hematocrit Measuring
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 28, 2020 | 0 | 0 | 0 | api.fda.gov |
| Abbott Point Of Care Inc. | Princeton, NJ, United States | Complaint file establishment, Manufacturer, Specification developer | 1 | February 28, 2020 | 0 | 1 | 0 | api.fda.gov |
| Andreas Hettich GMBH | TUTTLINGEN Baden-Wurttemberg, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Beckman Coulter, Inc. | Brea, CA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Beckman Coulter, Inc. | Miami, FL, United States | 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 | |
| Nova Biomedical Corporation | Waltham, MA, United States | Complaint file establishment, Manufacturer, Remanufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Nova Biomedical Corporation | Billerica, MA, United States | Manufacturer, Remanufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Radiometer Minneapolis | New Brighton, MN, United States | Manufacturer | 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 |
Updated February 28, 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.