Data / Medical devices / Control, Hematocrit
Control, Hematocrit (GLK): 11 FDA-registered makers in 4 countries
11 establishments in 4 countries are registered with the FDA to make Control, Hematocrit (product code GLK, Class 2, 21 CFR 864.8625). 4 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 7 510(k) clearances under this code, the latest on May 10, 2013, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- GLK
- Device class
- 2
- Regulation
- 864.8625
- Medical specialty
- Hematology
Makers by country
| Country | Makers |
|---|---|
| United States | 8 |
| Netherlands | 1 |
| Canada | 1 |
| China | 1 |
Makers of Control, Hematocrit
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 |
|---|---|---|---|---|---|---|---|---|
| Bionostics, Inc. | Devens, MA, United States | Contract manufacturer, Manufacturer | 1 | July 26, 1996 | 0 | 0 | 0 | api.fda.gov |
| Eurotrol B.V. | EDE Gelderland, Netherlands | Manufacturer | 1 | May 10, 2013 | 0 | 0 | 0 | api.fda.gov |
| Siemens Healthcare Diagnostics Inc | East Walpole, MA, United States | Specification developer | 1 | July 26, 1996 | 0 | 0 | 0 | api.fda.gov |
| Siemens Healthcare Diagnostics Inc. | Tarrytown, NY, United States | Complaint file establishment, Specification developer | 1 | July 26, 1996 | 0 | 0 | 0 | api.fda.gov |
| Abbott Point Of Care Canada Limited | Ottawa Ontario, Canada | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Edan Instruments, Inc. | Shenzhen Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Instrumentation Laboratory Co. | Bedford, MA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Instrumentation Laboratory Co. | Orangeburg, NY, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Richmond Diagnostics, Inc. | North Brunswick, NJ, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Stanbio Laboratory | Boerne, TX, United States | Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| STS Corporation | Duluth, GA, United States | Complaint file establishment, Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated May 10, 2013. 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.